Ischemic CardiomyopathySTRAICTNCT04190394
Comparison of Two Exercise Training Modes on Left Myocardial Regional Function After Myocardial Infarction Evaluated by 2D Strain Ultrasound
A study testing Intermittent retraining program. in people with Ischemic Cardiomyopathy, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Ischemic cardiomyopathy, defined by a deficiency in oxygenation of the myocardium due to a narrowing of the coronary arteries, is a major problem for public health. Medicinally-treated or re-vascularized cardiovascular rehabilitation following myocardial infarction has shown undeniable benefits in decreasing the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- Intermittent retraining program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Mar 2020to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient must have given free informed consent and signed the consent form
- patient must be affiliated to or be covered by a health insurance scheme.
- patient must be an adult aged ≥ 18 to ≤ 75 years old.
- Patient must have had a first episode of myocardial infarction treated via medical treatment or by revascularization like a percutaneous transluminal angioplasty (only if the patient has had complete revascularization) at least 6 weeks previously.
Who cannot join
- The patient is participating in another intervention study or has taken part in another interventional study in the past 3 months
- The patient is in an exclusion period determined by a previous study
- The patient is often under curatorship, tutorship or advisorship.
- It is impossible to give the patient clear information
- The patient refuses to sign the consent form
- The patient is pregnant, about to give birth or breastfeeding
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- The patient has a contraindication for retraining
- The patient has a prosthetic heart valve
- The patient has severe valve disorder
- The patient requires cardiac stimulation
- The patient has an automatic implantable defibrillator
- The patient has sinus tachycardia, sinus bradycardia or sinus arrhythmia
- The patient has non-controlled high blood pressure
- The patient has a ventricular ejection fraction < 45%
- The patient has already participated in a cardiac rehabilitation program less than a year before
- The patient has a relapse of myocardial ischaemia during the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Lavarin, Centre de Rééducation Cardiaque,1 Rue Mère Térésa,
Avignon, Vaucluse, 84000
Nîmes University Hospital
Nîmes, Gard, 30000
About this study
Official title: Comparison of Two Exercise Training Modalities on Left Myocardial Regional Function After MI (Myocardial Infarction) Evaluated by 2D Strain Ultrasound - a Randomized Controlled Bicentric Study
Ischemic cardiomyopathy, defined by a deficiency in oxygenation of the myocardium due to a narrowing of the coronary arteries, is a major problem for public health. Medicinally-treated or re-vascularized cardiovascular rehabilitation following myocardial infarction has shown undeniable benefits in decreasing the overall mortality rate (13-26%), cardiovascular mortality (26-36%) and morbidity, by controlling cardiovascular risk factors and improving tolerance to effort and consequently improving the quality of life. Since the integration of physical exercise into the rehabilitation programs of patients suffering from coronary disease in the mid-90s, and throughout the following decade, the exercise training program has mainly relied on moderately intense continuous exercises (CONT) the aim of which is to improve the aerobic capacity. These efforts typically consist of performing a submaximal exercise with an intensity of 50 to 80% of the maximum capacity for effort (established according to studies depending on the maximum or reserve heart rate or even peak power, measured when performing a first test, then a progressive and maximum test), and a constant duration (about 20 to 60 minutes). In the 2000s, under the aegis of Scandinavian teams, the intermittent mode (IT) appeared, characterized by alternating high intensity efforts of a short duration with active recuperation phases (Rognmo et al., 2004). Superiority of the IT mode over the CONT mode is generally observed on aerobic capacity for effort, usually gauged via the maximal oxygen consumption peak measured during a graded and maximum effort test. An important methodological bias in the comparison of the two modalities, within meta-analyses or even in the same randomized controlled trial, is the absence of control/pairing on the overall volume of training. At the present time, and to the best of our knowledge, there have been no studies to compare the effects of CONT versus IT modes on the systolic or diastolic function of the myocardial region by 2D-strain following myocardial infarction. The aim of our study was to compare the outcomes of 2D strain scans upon inclusion and after 8 weeks of cardiovascular physiotherapy for 2 groups of patients benefiting from a CONT or IT program.
Read the detailed description
This is a bi-centric randomised comparative superiority trial, blinded to the evaluator for 2 parallel groups (interventional intermittent training group "IT" vs a continuous training control group "CONT") with a 1:1 ratio.
Patients admitted for care at the cardiology departments of Nîmes University Hospital and the cardiology department of Avignon hospital for a first myocardial infarction dating back to less than 6 weeks will be pre-selected. The patients will receive both written and oral information about the study.
Patients are then referred to the Physical Medicine and Cardiac Rehabilitation departments at Nîmes University Hospital for the Nîmes site and the Lavarin Cardio Rehabilitation Center for the Avignon site for the inclusion visit at which the information about the study is given. Patients will be included in the study after signing a consent form.
The investigators then proceed with a maximal aerobic exercise test to evaluate cardiovascular endurance capacities and the suitability of the cardiovascular training program. Cardiac ultrasound is also performed, questionnaires about the quality of life are administered and biological doses are measured.
Then a stratified randomisation on the patient's age and sex will be performed to assign the subject either to the "IT intermittent training group" group, the experimental group, or to the "CONT continuous training" group, the control group which corresponds to the general care usually given.
Comparison of these two groups constitutes the methodological framework for this research. In the "IT intermittent training group (the experimental group), the patient benefits from a retraining program according to intermittent mode for 8 weeks, with three 45-minute sessions per week.
In the "CONT continuous training" group (the control group), the patient benefits from a retraining program according to the continuous mode for 8 weeks, with three 40-minute sessions per week.
At the end of the retraining program, at 8 weeks, an exercise test and a 2D Strain scan are performed, biological doses are taken and quality of life questionnaires are handed out.
Each patient will be followed 2 months after inclusion. The duration of inclusion period will be 18 months. The total duration of the test will be 24 months.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- Intermittent retraining program.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent retraining program.Other
Patient benefits from an intermittent retraining program for 8 weeks, with three 45-minute sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Patients following the CONT program | No intervention | In the " CONT continuous training" group, the control group, the patient benefits from a retraining program according to the continuous mode (see details in section 3.4) for 8 weeks, with three 40-minute sessions per week. |
| Patients following the IT program | Experimental | In the "IT intermittent training group", group, (the experimental group), the patient benefits from a retraining program according to the intermittent mode (see details in section 3.4) for 8 weeks, with three 45-minute sessions per week. Receives: Other: Intermittent retraining program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal systolic strain on Day 0.
All patients, whatever group they have been assigned to, will undergo a 2D Strain scan at the inclusion visit, before starting continuous (CONT) or intermittent (IT) cardiovascular rehabilitation.The overall longitudinal systolic strain (s-1) of the left ventricle will be measured (%) by echocardiography.
Measured: Day 0
Longitudinal systolic strain at Week 8.
All patients whatever group they have been assigned to will undergo a 2D Strain scan after undergoing 8 weeks continuous (CONT) or intermittent (IT) of cardiovascular physiotherapy.The overall longitudinal strain (s-1) of the left ventricle will be measured (%) by echocardiography.
Measured: Week 8
Secondary outcomes (111)
Longitudinal diastolic strain on Day 0
Longitudinal diastolic strain (s-1) will be measured by echocardiography before undergoing CONT or IT cardiovascular rehabilitation.
Measured: D0
Longitudinal diastolic strain at Week 8
Longitudinal diastolic strain (s-1) will be measured by echocardiography after 8 weeks of CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Circumferential strain on Day 0
Circumferential strain (s-1) will be measured by echocardiography before beginning CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Circumferential strain at Week 8
Circumferential strain (s-1) will be measured by echocardiography after undergoing CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Systolic radial strain on Day 0
Systolic radial strain (%) will be measured by echocardiography before beginning CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Systolic radial strain at Week 8
Systolic radial strain (%) will be measured by echocardiography after undergoing CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Diastolic radial strain on Day 0
Diastolic radial strain (s-1) will be measured by echocardiography before beginning CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Diastolic radial strain at Week 8
Diastolic radial strain (S-1) will be measured by echocardiography after undergoing CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Systolic circumferential strain on Day 0
Systolic circumferential strain (s-1) will be measured before undergoing CONT or IT cardiovascular rehabilitation.
Measured: D0
Systolic circumferential strain at Week 8
Systolic circumferential radial strain (s-1) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Diastolic circumferential strain on Day 0
Diastolic circumferential strain (s-1) will be measured before undergoing CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Diastolic circumferential strain at Week 8
Diastolic circumferential strain (s-1) will be measured after undergoing CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Apical rotation on Day 0
Apical rotation (°) will be measured before undergoing CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Apical rotation at Week 8
Apical rotation (°) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Basal rotation on Day 0
Basal rotation (°) will be measured before undergoing CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Basal rotation at Week 8
Basal rotation (°) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Ventricular torsion on Day 0
Ventricular torsion (°) will be measured before undergoing CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Ventricular torsion at Week 8
Ventricular torsion (°) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Intraventricular asynchrony on Day 0
Intraventricular asynchrony (ms) will be measured before undergoing CONT or IT cardiovascular rehabilitation.
Measured: Day 0
Intraventricular asynchrony at Week 8
Intraventricular asynchrony (ms) will be measured after undergoing 8 weeks of CONT or IT cardiovascular rehabilitation.
Measured: Week 8
Cardiac morphology : Telesystolic volume on Day 0
Telesystolic volume wil be measured (mL) before starting cardiac rehabilitation.
Measured: D0
Cardiac morphology : Telesystolic volume at Week 8
Telesystolic volume wil be measured (mL) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : Telediastolic volume on Day 0
Telediastolic volume will be measured (mL) before starting cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : Telediastolic volume at Week 8
Telediastolic volume will be measured (mL) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : Left ventricle mass on Day 0
Left ventricle mass will be measured (g/m²) before starting cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : Left ventricle mass at Week 8
Left ventricle mass will be measured (g/m²) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : FEVG at Day 0
FEVG will be measured (%) before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : FEVG at Week 8
FEVG will be measured (%) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : S' wave on Day 0
S' wave will be measured (%) before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : S' wave at Week 8
S' wave will be measured (%) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : E/A ratio on Day 0
E/A ratio will be measured before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : E/A ratio at Week 8
E/A ratio will be measured after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : E' wave at Day 0
E' wave will be measured cm/s) before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : E' wave at Week 8
E' wave will be measured (cm/s) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : A' wave on Day 0
A' wave will be measured (cm/s) before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : A' wave at Week 8
A' wave will be measured (cm/s) after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : E/E' ratio on Day 0
E/E' ratio will be measured before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : E/E' ratio at Week 8
E/E' ratio will be measured after cardiac rehabilitation.
Measured: Week 8
Cardiac morphology : Systolic ejection volume on Day 0
Systolic ejection volume will be measured before cardiac rehabilitation.
Measured: Day 0
Cardiac morphology : Systolic ejection volume at Week 8
Systolic ejection volume will be measured after cardiac rehabilitation.
Measured: Week 8
Aerobic capacity: VO2max on Day 0
VO2max (mL/min/kg) is measured with a Jaeger Oxycon Pro ergospirometer before starting cardiac rehabilitation.
Measured: Day 0
Aerobic capacity: VO2max at Week 8
VO2max (mL/min/kg) is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Aerobic capacity: Maximal aerobic power (MAP) on Day 0
MAP (watts) is measured with a Jaeger Oxycon Pro ergospirometer before starting cardiac rehabilitation .
Measured: Day 0
Aerobic capacity : Maximal aerobic power (MAP) at Week 8
MAP (watts) is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation .
Measured: Week 8
Aerobic capacity: ventilation threshold (mL/min/kg) on Day 0
The ventilation threshold VT1 (mL/min/kg) is measured with a Jaeger Oxycon Pro before starting cardiac rehabilitation.
Measured: Day 0
Aerobic capacity: ventilation threshold (mL/min/kg) at Week 8
The ventilation threshold VT1 (mL/min/kg) is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Aerobic capacity: walking on Day 0
Performance at a 6-minute (m) walk is measured with a Jaeger Oxycon Pro ergospirometer before starting cardiac rehabilitation.
Measured: Day 0
Aerobic capacity: walking at Week 8
Performance at a 6-minute (m) walk is measured with a Jaeger Oxycon Pro ergospirometer after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Weight on Day 0
The patient's weight will be measured in kilograms before beginning cardiac rehabilitation.
Measured: Day 0
Weight at Week 8
The patient's weight will be measured in kilograms after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Height on Day 0
The patient's height will be measured in centimeters before beginning cardiac rehabilitation.
Measured: Day 0
Height at Week 8
The patient's height will be measured in centimeters after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Waist measurement on Day 0
The patient's waist measurement will be noted in centimeters before beginning cardiac rehabilitation.
Measured: Day 0
Waist measurement at Week 8
The patient's waist measurement will be noted in centimeters after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Body Mass Index on Day 0
The patient's Body Mass Index will be calculated in kg/m2 before beginning cardiac rehabilitation.
Measured: Day 0
Body Mass Index at Week 8
The patient's Body Mass Index will be calculated in in kg/m2 after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Medicinal treatment on Day 0
Any medicinal treatment that the patient may be following will be noted before beginning cardiac rehabilitation.
Measured: Day 0
Medicinal treatment at Week 8
Any medicinal treatment that the patient may be following will be noted after undergoing 8 weeks of cardiac rehabilitation.
Measured: Week 8
Hemoglobin in g/dL on Day 0
A blood sample will be taken before beginning cardiac rehabilitation and Hemoglobin will be measured in g/dL.
Measured: Day 0
Hemoglobin in g/dL at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Hemoglobin will be measured in g/dL.
Measured: Week 8
Percentage volume of Hematocrit on Day 0
A blood sample will be taken before beginning cardiac rehabilitation and Hematocrit will be measured as a percentage.
Measured: Day 0
Percentage volume of Hematocrit at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Hematocrit will be measured as a percentage.
Measured: Week 8
Mean Corpuscular Volume in femtoliters on Day 0
A blood sample will be taken before starting cardiac rehabilitation and Mean Corpuscular Volume will be measured in fL.
Measured: Day 0
Mean Corpuscular Volume in femtoliters at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Mean Corpuscular Volume will be measured in fL.
Measured: Week 8
Platelets in G/L on Day 0
A blood sample will be taken before starting cardiac rehabilitation and platelets will be measured in G/L.
Measured: Day 0
Platelets in G/L at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and platelets will be measured in G/L.
Measured: Week 8
Leukocytes in G/L on Day 0
A blood sample will be taken before starting cardiac rehabilitation and leukocytes will be measured in G/L.
Measured: Day 0
Leukocytes in G/L at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and leukocytes will be measured in G/L.
Measured: Week 8
C-reactive Protein on Day 0
A blood sample will be taken before beginning cardiac rehabilitation and C-reactive Protein will be measured in mg/L.
Measured: Day 0
C-reactive Protein at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and C-reactive Protein will be measured in mg/L.
Measured: Week 8
Potassium in millimoles per liter on Day 0
A blood sample will be taken before starting cardiac rehabilitation and potassium will be measured in mmol/l.
Measured: Day 0
Potassium in millimoles per liter at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and potassium will be measured in mmol/l.
Measured: Week 8
Sodium in millimoles per liter on Day 0
A blood sample will be taken before starting cardiac rehabilitation and sodium will be measured in mmol/l.
Measured: Day 0
Sodium in millimoles per liter at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and sodium will be measured in mmol/l.
Measured: Week 8
Urea on Day 0
A blood sample will be taken before starting cardiac rehabilitation and urea will be measured in milligrams per deciliter.
Measured: Day 0
Urea at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and urea will be measured in milligrams per deciliter.
Measured: Week 8
Creatinine on Day 0
A blood sample will be taken before starting cardiac rehabilitation and creatinine will be measured in milligrams per deciliter.
Measured: Day 0
Creatinine at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and creatinine will be measured in milligrams per deciliter.
Measured: Week 8
Fasting glucose on Day 0
A blood sample will be taken before starting cardiac rehabilitation and fasting glucose will be measured in milligrams per deciliter.
Measured: Day 0
Fasting glucose at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and creatinine will be measured in milligrams per deciliter.
Measured: Week 8
HbA1c on Day 0
A blood sample will be taken before starting cardiac rehabilitation and HbA1c will be measured as a percentage.
Measured: Day 0
HbA1c at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and HbA1c will be measured as a percentage.
Measured: Week 8
Aspartate Aminotransferase on Day 0
A blood sample will be taken before starting cardiac rehabilitation and Aspartate Aminotransferase will be measured in units per liter.
Measured: Day 0
Aspartate Aminotransferase at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Aspartate Aminotransferase will be measured in units per liter.
Measured: Week 8
Alanine Aminotransferase on Day 0
A blood sample will be taken before starting cardiac rehabilitation and Alanine Aminotransferase will be measured in units per liter.
Measured: Day 0
Alanine Aminotransferase at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Alanine Aminotransferase will be measured in units per liter.
Measured: Week 8
Alkaline phosphatase on Day 0
A blood sample will be taken before starting cardiac rehabilitation and Alkaline phosphatase will be measured in units per liter.
Measured: Day 0
Alkaline phosphatase at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Alkaline phosphatase will be measured in units per liter.
, bilirubin,Gamma-glutamyltransferase, total cholesterol, Low Density Lipoprotein-cholesterol, High Density Lipoprotein-cholesterol, triglycerides, NT-proB-type Natriuretic Peptides, micro-RNA (miRNA-22, miRNA208-a and miRNA 423-5p).
Measured: Week 8
Creatine phosphokinase on Day 0
A blood sample will be taken before starting cardiac rehabilitation Creatine phosphokinase will be measured in units per liter.
Measured: Day 0
Creatine phosphokinase at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Creatine phosphokinase will be measured in units per liter.
Measured: Week 8
Bilirubin on Day 0
A blood sample will be taken before starting cardiac rehabilitation and bilirubin will be measured in milligrams per deciliter.
Measured: Day 0
Bilirubin at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and bilirubin will be measured in milligrams per deciliter.
Measured: Week 8
Gamma-glutamyltransferase on Day 0
A blood sample will be taken before starting cardiac rehabilitation and gamma-glutamyltransferase will be measured in units per liter.
Measured: Day 0
Gamma-glutamyltransferase at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and Gamma-glutamyltransferase will be measured in units per liter.
Measured: Week 8
Total cholesterol on Day 0
A blood sample will be taken before starting cardiac rehabilitation and total cholesterol will be measured in milligrams per deciliter.
Measured: Day 0
Total cholesterol at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and bilirubin will be measured in milligrams per deciliter.
Measured: Week 8
Low Density Lipoprotein-cholesterol on Day 0
A blood sample will be taken before starting cardiac rehabilitation and low density lipoprotein-cholesterol will be measured in milligrams per deciliter.
Measured: Day 0
Low Density Lipoprotein-cholesterol at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and low density lipoprotein-cholesterol will be measured in milligrams per deciliter.
Measured: Week 8
High Density Lipoprotein-cholesterol on Day 0
A blood sample will be taken before starting cardiac rehabilitation and high density lipoprotein-cholesterol will be measured in milligrams per deciliter.
Measured: Day 0
High Density Lipoprotein-cholesterol at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and high density lipoprotein-cholesterol will be measured in milligrams per deciliter.
Measured: Week 8
Triglycerides on Day 0
A blood sample will be taken before starting cardiac rehabilitation and triglycerides will be measured in milligrams per deciliter.
Measured: Day 0
Triglycerides at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and triglycerides will be measured in milligrams per deciliter.
Measured: Week 8
NT-proB-type Natriuretic Peptides on Day 0
A blood sample will be taken before starting cardiac rehabilitation and NT-proB-type natriuretic peptides will be measured in picograms per milliliter.
Measured: Day 0
NT-proB-type Natriuretic Peptides at Week 8
A blood sample will be taken after undergoing cardiac rehabilitation for 8 weeks and NT-proB-type natriuretic peptides will be measured in picograms per milliliter.
Measured: Week 8
Micro-RNA dosage (miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) on Day 0
Micro-RNAs (including, notably, miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) dosed via reverse-transcriptase quantitative polymerase chain reaction (PCR). PCR consists of an organic extraction stage followed by immobilization of RNA on an apparatus to purify it before elution. PCR provides numerous copies of a chosen DNA sequence. Real time quantitative PCR provides the quantity of DNA at each amplification cycle thanks to SYBR® Green, an intercalating fluorescent DNA agent, which emits a quantity of fluorescence for each amplicon produced. Fluorescence is thus directly proportional to the quantity of DNA in the sample. RNA extractions will be made from 200 μL of plasma collected before the patient starts cardiac rehabilitation and analyzed by researchers at Aix-Marseille University - INSERM, UMR 1260 C2VN Center for Cardiovascular and Nutrition research. Frozen samples will be shipped from Nîmes and Avignon to Marseille by Cryoglobe package.
Measured: Day 0
Micro-RNA dosage (miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) at Week 8
Micro-RNAs (including, notably, miRNA22, miRNA122, miRNA150, miRNA208 a/b and miRNA 423-5p) dosed via reverse-transcriptase quantitative polymerase chain reaction (PCR). PCR consists of an organic extraction stage followed by immobilization of RNA on an apparatus to purify it before elution. PCR provides numerous copies of a chosen DNA sequence. Real time quantitative PCR provides the quantity of DNA at each amplification cycle thanks to SYBR® Green, an intercalating fluorescent DNA agent, which emits a quantity of fluorescence for each amplicon produced. Fluorescence is thus directly proportional to the quantity of DNA in the sample. RNA extractions will be made from 200 μL of plasma collected after the patient has had 8 weeks of cardiac rehabilitation and analyzed by researchers at Aix-Marseille University - INSERM, UMR 1260 C2VN Center for Cardiovascular and Nutrition research. Frozen samples will be shipped from Nîmes and Avignon to Marseille by Cryoglobe package.
Measured: Week 8
Quality of life according to the WHOQOL-BREF Questionnaire on Day 0
Before starting cardiac rehabilitation, the patient's quality of life is measured with the WHOQOL-BREF, a short version of the WHOQOL-100 quality of life assessment developed by the WHOQOL group with fifteen international field centres, simultaneously (Orley \& Kuyken, 1994; Szabo, 1996; WHOQOL Group 1994a, 1994b, 1995). The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction divided into four domains: Physical health with 7 items (DOM1), psychological health with 6 items (DOM2), social relationships with 3 items (DOM3) and environmental health with 8 items (DOM4). Each item is rated on a 5-point Likert scale.The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score.
Measured: Day 0
Quality of life according to the WHOQOL-BREF Questionnaire at Week 8
After undergoing cardiac rehabilitation for 8 weeks, the patient's quality of life is measured with the WHOQOL-BREF, a short version of the WHOQOL-100 quality of life assessment developed by the WHOQOL group with fifteen international field centres, simultaneously (Orley \& Kuyken, 1994; Szabo, 1996; WHOQOL Group 1994a, 1994b, 1995). The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction divided into four domains: Physical health with 7 items (DOM1), psychological health with 6 items (DOM2), social relationships with 3 items (DOM3) and environmental health with 8 items (DOM4). Each item is rated on a 5-point Likert scale.The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score.
Measured: Week 8
Quality of life according to the MacNew Questionnaire at Day 0
Before starting cardiac rehabilitation, the patient's quality of life is measured with the MacNew Questionnaire, which is a self-administered modified version of the original QLMI instrument. The MacNew is designed to assess the patient's feelings about how Myocardial Infarction affects daily functioning and contains 27 items with a global Health-Related Quality of Life (HRQoL) score and subscales regarding physical limitation, emotional, and social function. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs.The items and scales are scored from 1 (low HRQoL) to 7 (high HRQoL), and the minimal important difference on each MacNew scale is 0.50 points. The time frame for the MacNew is the previous two weeks.
Measured: Day 0
Quality of life according to the MacNew Questionnaire at Week 8
After undergoing cardiac rehabilitation for 8 weeks, the patient's quality of life is measured with the MacNew Questionnaire, which is a self-administered modified version of the original QLMI instrument.The MacNew is designed to assess the patient's feelings about how Myocardial Infarction affects daily functioning and contains 27 items with a global Health-Related Quality of Life (HRQoL) score and subscales regarding physical limitation, emotional, and social function. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The items and scales are scored from 1 (low HRQoL) to 7 (high HRQoL), and the minimal important difference on each MacNew scale is 0.50 points. The time frame for the MacNew is the previous two weeks.
Measured: Week 8
Observance of the rehabilitation program
An attendance sheet must be filled in by all patients, each time they attend their rehabilitation session whether they are assigned to the the control group (CONT) with three 40-minute sessions per week or the experimental group doing intermittent training (IT) with three 45-minute sessions per week.
Measured: Day 0 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start12 Mar 2020
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud DUPEYRON, Dr., Principal investigator, CHU de Nîmes (Nîmes University Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190394
- Sponsor's protocol ID
- NIMAO/2018-03/AD-01
- Other IDs
- 2019-A01010-57
- Acronym
- STRAICT
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Obert P, Nottin S, Belvisi C, Robert C, Miramont V, de France C, Carlioz R, Landrier JF, Poirier P, Dupeyron A. A comprehensive analysis of the impact of high-intensity interval vs. moderate-intensity continuous training on global and regional myocardial function in patients early after acute myocardial infarction: the STRAICT randomized controlled trial. Eur J Prev Cardiol. 2026 Apr 22;33(6):883-894. doi: 10.1093/eurjpc/zwaf127.
PubMed 40042823
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Exercise Training Modalities on Left Myocardial Regional Function After MI (Myocardial Infarction) Evaluated by 2D Strain Ultrasound - a Randomized Controlled Bicentric Study
- ClinicalTrials.gov ID
- NCT04190394
- Acronym / sponsor ID
- STRAICT / NIMAO/2018-03/AD-01
- Conditions
- Ischemic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ischemic cardiomyopathy, defined by a deficiency in oxygenation of the myocardium due to a narrowing of the coronary arteries, is a major problem for public health. Medicinally-treated or re-vascularized cardiovascular rehabilitation following myocardial infarction has shown undeniable benefits in decreasing the overall mortality rate (13-26%), cardiovascular mortality (26-36%) and morbidity, by controlling cardiovascular risk factors and improving tolerance to effort and consequently improving the quality of life. Since the integration of physical exercise into the rehabilitation programs of patients suffering from coronary disease in the mid-90s, and throughout the following decade, the exercise training program has mainly relied on moderately intense continuous exercises (CONT) the aim of which is to improve the aerobic capacity. These efforts typically consist of performing a submaximal exercise with an intensity of 50 to 80% of the maximum capacity for effort (established according to studies depending on the maximum or reserve heart rate or even peak power, measured when performing a first test, then a progressive and maximum test), and a constant duration (about 20 to 60 minutes). In the 2000s, under the aegis of Scandinavian teams, the intermittent mode (IT) appeared, characterized by alternating high intensity efforts of a short duration with active recuperation phases (Rognmo et al., 2004). Superiority of the IT mode over the CONT mode is generally observed on aerobic capacity for effort, usually gauged via the maximal oxygen consumption peak measured during a graded and maximum effort test. An important methodological bias in the comparison of the two modalities, within meta-analyses or even in the same randomized controlled trial, is the absence of control/pairing on the overall volume of training. At the present time, and to the best of our knowledge, there have been no studies to compare the effects of CONT versus IT modes on the systolic or diastolic function of the myocardial region by 2D-strain following myocardial infarction. The aim of our study was to compare the outcomes of 2D strain scans upon inclusion and after 8 weeks of cardiovascular physiotherapy for 2 groups of patients benefiting from a CONT or IT program.
Detailed description
This is a bi-centric randomised comparative superiority trial, blinded to the evaluator for 2 parallel groups (interventional intermittent training group "IT" vs a continuous training control group "CONT") with a 1:1 ratio.
Patients admitted for care at the cardiology departments of Nîmes University Hospital and the cardiology department of Avignon hospital for a first myocardial infarction dating back to less than 6 weeks will be pre-selected. The patients will receive both written and oral information about the study.
Patients are then referred to the Physical Medicine and Cardiac Rehabilitation departments at Nîmes University Hospital for the Nîmes site and the Lavarin Cardio Rehabilitation Center for the Avignon site for the inclusion visit at which the information about the study is given. Patients will be included in the study after signing a consent form.
The investigators then proceed with a maximal aerobic exercise test to evaluate cardiovascular endurance capacities and the suitability of the cardiovascular training program. Cardiac ultrasound is also performed, questionnaires about the quality of life are administered and biological doses are measured.
Then a stratified randomisation on the patient's age and sex will be performed to assign the subject either to the "IT intermittent training group" group, the experimental group, or to the "CONT continuous training" group, the control group which corresponds to the general care usually given.
Comparison of these two groups constitutes the methodological framework for this research. In the "IT intermittent training group (the experimental group), the patient benefits from a retraining program according to intermittent mode for 8 weeks, with three 45-minute sessions per week.
In the "CONT continuous training" group (the control group), the patient benefits from a retraining program according to the continuous mode for 8 weeks, with three 40-minute sessions per week.
At the end of the retraining program, at 8 weeks, an exercise test and a 2D Strain scan are performed, biological doses are taken and quality of life questionnaires are handed out.
Each patient will be followed 2 months after inclusion. The duration of inclusion period will be 18 months. The total duration of the test will be 24 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients following the CONT program | No intervention | –In the " CONT continuous training" group, the control group, the patient benefits from a retraining program according to the continuous mode (see details in section 3.4) for 8 weeks, with three 40-minute sessions per week. |
| Patients following the IT program | Experimental | Other: Intermittent retraining program.In the "IT intermittent training group", group, (the experimental group), the patient benefits from a retraining program according to the intermittent mode (see details in section 3.4) for 8 weeks, with three 45-minute sessions per week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient must have given free informed consent and signed the consent form
- patient must be affiliated to or be covered by a health insurance scheme.
- patient must be an adult aged ≥ 18 to ≤ 75 years old.
- Patient must have had a first episode of myocardial infarction treated via medical treatment or by revascularization like a percutaneous transluminal angioplasty (only if the patient has had complete revascularization) at least 6 weeks previously.
Key exclusion criteria (16 listed)
- The patient is participating in another intervention study or has taken part in another interventional study in the past 3 months
- The patient is in an exclusion period determined by a previous study
- The patient is often under curatorship, tutorship or advisorship.
- It is impossible to give the patient clear information
- The patient refuses to sign the consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent retraining program.Patient benefits from an intermittent retraining program for 8 weeks, with three 45-minute sessions per week. | Other | Patients following the IT program |
Primary outcome
Longitudinal systolic strain on Day 0.
Time frame: Day 0
All patients, whatever group they have been assigned to, will undergo a 2D Strain scan at the inclusion visit, before starting continuous (CONT) or intermittent (IT) cardiovascular rehabilitation.The overall longitudinal systolic strain (s-1) of the left ventricle will be measured (%) by echocardiography.
Longitudinal systolic strain at Week 8.
Time frame: Week 8
All patients whatever group they have been assigned to will undergo a 2D Strain scan after undergoing 8 weeks continuous (CONT) or intermittent (IT) of cardiovascular physiotherapy.The overall longitudinal strain (s-1) of the left ventricle will be measured (%) by echocardiography.
111 secondary outcomes
Longitudinal diastolic strain on Day 0
Time frame: D0
Longitudinal diastolic strain at Week 8
Time frame: Week 8
Circumferential strain on Day 0
Time frame: Day 0
Circumferential strain at Week 8
Time frame: Week 8
Systolic radial strain on Day 0
Time frame: Day 0
Systolic radial strain at Week 8
Time frame: Week 8
Diastolic radial strain on Day 0
Time frame: Day 0
Diastolic radial strain at Week 8
Time frame: Week 8
Systolic circumferential strain on Day 0
Time frame: D0
Systolic circumferential strain at Week 8
Time frame: Week 8
Diastolic circumferential strain on Day 0
Time frame: Day 0
Diastolic circumferential strain at Week 8
Time frame: Week 8
Apical rotation on Day 0
Time frame: Day 0
Apical rotation at Week 8
Time frame: Week 8
Basal rotation on Day 0
Time frame: Day 0
Basal rotation at Week 8
Time frame: Week 8
Ventricular torsion on Day 0
Time frame: Day 0
Ventricular torsion at Week 8
Time frame: Week 8
Intraventricular asynchrony on Day 0
Time frame: Day 0
Intraventricular asynchrony at Week 8
Time frame: Week 8
Cardiac morphology : Telesystolic volume on Day 0
Time frame: D0
Cardiac morphology : Telesystolic volume at Week 8
Time frame: Week 8
Cardiac morphology : Telediastolic volume on Day 0
Time frame: Day 0
Cardiac morphology : Telediastolic volume at Week 8
Time frame: Week 8
Cardiac morphology : Left ventricle mass on Day 0
Time frame: Day 0
Cardiac morphology : Left ventricle mass at Week 8
Time frame: Week 8
Cardiac morphology : FEVG at Day 0
Time frame: Day 0
Cardiac morphology : FEVG at Week 8
Time frame: Week 8
Cardiac morphology : S' wave on Day 0
Time frame: Day 0
Cardiac morphology : S' wave at Week 8
Time frame: Week 8
Cardiac morphology : E/A ratio on Day 0
Time frame: Day 0
Cardiac morphology : E/A ratio at Week 8
Time frame: Week 8
Cardiac morphology : E' wave at Day 0
Time frame: Day 0
Cardiac morphology : E' wave at Week 8
Time frame: Week 8
Cardiac morphology : A' wave on Day 0
Time frame: Day 0
Cardiac morphology : A' wave at Week 8
Time frame: Week 8
Cardiac morphology : E/E' ratio on Day 0
Time frame: Day 0
Cardiac morphology : E/E' ratio at Week 8
Time frame: Week 8
Cardiac morphology : Systolic ejection volume on Day 0
Time frame: Day 0
Cardiac morphology : Systolic ejection volume at Week 8
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 40042823Obert P, Nottin S, Belvisi C, Robert C, Miramont V, de France C, Carlioz R, Landrier JF, Poirier P, Dupeyron A. A comprehensive analysis of the impact of high-intensity interval vs. moderate-intensity continuous training on global and regional myocardial function in patients early after acute myocardial infarction: the STRAICT randomized controlled trial. Eur J Prev Cardiol. 2026 Apr 22;33(6):883-894. doi: 10.1093/eurjpc/zwaf127.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud DUPEYRON, Dr. principal investigator
CHU de Nîmes (Nîmes University Hospital)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent retraining program. in people with Ischemic Cardiomyopathy, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal systolic strain on Day 0. (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.