Acute Myocardial Infarction (AMI)NCT07155928
The Effect of Cardiac Rehabilitation on Left Ventricular Remodeling in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
A study testing Cardiac Rehabilitation and Primary Percutaneous Coronary Intervention in people with Acute Myocardial Infarction (AMI) and PCI Patients, run by Assiut University.
Trial summary
Cardiac rehabilitation has proven to improve the functional capacity of patients who had acute myocardial infarction. However, its effect on Left ventricular remodeling following an MI event treated with Primary PCI is not yet fully understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), PCI Patients, Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Cardiac Rehabilitation and Primary Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Dec 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent successful primary PCI within 24 hours of symptom onset.
- Hemodynamically stable and able to participate in rehabilitation.
Who cannot join
- Stage IV Heart failure, LVEF < 30%
- Life-threatening arrhythmias
- Unstable Angina
- Severe Valvular Diseases
- Uncontrolled Hypertension
- CKD Stages IV and V
Show all 9Show fewer
- Hypothyroidism
- Cardiomyopathy
- Inability to ambulate or consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Cardiac rehabilitation has proven to improve the functional capacity of patients who had acute myocardial infarction. However, its effect on Left ventricular remodeling following an MI event treated with Primary PCI is not yet fully understood. So, for this randomized controlled trial our objectives are as follows:
- Primary: To assess the effect of a structured CR program on LV remodeling parameters (LVEF, LVESV, LVEDV, LVESD, LVEDD + SWMA) in STEMI patients treated with primary PCI.
- Secondary: To evaluate changes in exercise capacity, heart rate recovery and clinical outcomes such as major adverse cardiovascular events and the effect of CR on the patients' Quality of Life.
Read more
These results will be compared to the same parameters in a control group that will not undergo cardiac rehabilitation to properly assess the effect of cardiac rehab.
Participants in the intervention group will be asked to undergo a supervised CR program based on published guidelines (FITT principle). The core will be a moderate-intensity aerobic exercise regimen (e.g. treadmill or cycle ergometer) 2-3 times per week for 12 weeks. Each session will last ~20-60 minutes of exercise followed by cool-down, with intensity gradually increased to High intensity interval training (HIIT) in low-moderate risk individuals, as it has shown better improvement in cardiovascular health while being safe in MI patients. Resistance exercises (e.g. light weights or band exercises) will also be included twice weekly. Exercise dose (frequency, intensity, time) will be tracked. Physical therapists will supervise all sessions in an outpatient CR facility or affiliated gym. Patients' vitals and ECG will be monitored during initial sessions for safety.
Read the detailed description
ST-segment elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality worldwide. Primary percutaneous coronary intervention (PCI) is the gold standard for reperfusion therapy in STEMI, significantly improving survival rates. However, adverse left ventricular (LV) remodeling post-STEMI can lead to heart failure, poor clinical outcomes and deterioration in patients' quality of life.
Cardiac rehabilitation (CR) is a multidisciplinary intervention designed to optimize cardiovascular recovery. It involves a spectrum of interventions including a structured exercise program, patient education, nutritional counseling, risk factor modification and psychosocial support. CR is divided into 4 stages. Stage I is in-hospital exercise (early mobilization and patient education). Stage II is early outpatient supervised rehabilitation in rehabilitation centers lasting 3 months post-PCI. Stage III starts at 3-12 months and is usually home-based rehabilitation with frequent visits to rehabilitation centers. Stage IV is long term rehab where the patient continues to exercise and commit to a healthy lifestyle to prevent further episodes of cardiovascular disease. Research has shown that stage II is the most crucial of them all, and starting during early in-hospital setting has shown no further improvement in cardiovascular health.
Exercise-based programs, have especially shown beneficial effects on LV function post-AMI, improving exercise capacity and potentially limiting adverse remodeling process. It has been reported that supervised exercise training after STEMI significantly increased LVEF and reduced the rate of unfavorable remodeling at 6 months compared to usual care.
Moreover, there was a significant reduction in post-treatment LV mass, EF, and LV dimensions relative to pretreatment. It has also been suggested that early initiation of CR may reduce systemic inflammation and promote favorable ventricular remodeling.
However, other studies have shown that CR may not have a clinically significant improvement in LV parameters despite the overall improvement in patient's exercise capacity , but these studies were performed with a small sample size. Other trials have shown mixed results, with some showing favorable remodeling after exercise therapy, and some showing no improvement in cardiac dimensions. Another study mentioned that CR may have a positive effect on LV diastolic dysfunction, without any change to LV dimensions.
As such, the exact impact of CR on LV remodeling specifically in primary PCI-treated STEMI patients requires further clarification, especially with recent evidence highlighting its potential benefits.
Such controversy provides adequate foundation to further research this topic with a larger sample size, inclusion of both sexes, with individualization of exercise protocols based on each patient's tolerance.
- Conditions
- Acute Myocardial Infarction (AMI), PCI Patients, Percutaneous Coronary Intervention (PCI), Primary Percutaneous Coronary Intervention, Left Ventricle Remodeling
- Being tested
- Cardiac Rehabilitation, Primary Percutaneous Coronary Intervention
- Keywords
- Cardiac Rehabilitation, Acute Myocardial Infarction, Primary Percutaneous Coronary Intervention, Left Ventricular Remodeling, Ejection fraction, End-systolic volume, End-systolic diameter, End-diastolic volume, End-diastolic diameter, Functional capacity, Aerobic exercise, Resistance Training
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationBehavioural
- The cardiac rehabilitation program include supervised exercise training, patient education, and risk factor modification.
- CR starts 1-3 weeks after PCI (based on the patient's general condition) and lasting 12 weeks thereafter.
- Patients will undergo a supervised CR program based on published guidelines (FITT principle). The core will be a moderate-intensity aerobic exercise regimen (e.g. treadmill or cycle ergometer) 2-3 times per week for 12 weeks. Each session will last ~20-60 minutes of exercise followed by cool-down, with intensity gradually increased to High intensity interval training (HIIT) in low-moderate risk individuals. Resistance exercises (e.g. light weights or band exercises) will also be included twice weekly. Exercise dose (frequency, intensity, time) will be tracked. Physical therapists will supervise all sessions in an outpatient CR facility or affiliated gym. Patients' vitals and ECG will be monitored during initial sessions for safety.
Primary Percutaneous Coronary InterventionProcedure or surgery
Patients will undergo Primary Percutaneous Coronary Intervention (PPCI) within 24 hours of symptom onset for urgent revascularization of the occluded coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Standard Treatment + Cardiac Rehabilitation Receives: Behavioral: Cardiac Rehabilitation; Procedure: Primary Percutaneous Coronary Intervention |
| Control Group | Active comparator | Standrad Treatment Only Receives: Procedure: Primary Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LV remodeling assessed by LV ejection fraction (LVEF)
LVEF assessed in "%"
Measured: Before and after a 3-month cardiac rehabilitation program
Change in LV remodeling assessed by LV end-systolic Volume (LVESV), LV end-diastolic Volume (LVEDV)
LVESV and LVEDV are both assessed in mL
Measured: Before and after a 3-month cardiac rehabilitation program
Change in LV remodeling assessed by LV end-systolic Diameter (LVESD) and LV end-diastolic Diameter (LVEDD).
LVESD and LVEDD are both assessed in millimeters
Measured: Before and after a 3-month cardiac rehabilitation program
Secondary outcomes (3)
Exercise capacity assessed in METs
Measured: Before and after a 3-month cardiac rehabilitation program
Heart rate recovery post-exercise.
HRR is measured in BPM
Measured: Before and after a 3-month cardiac rehabilitation program
Incidence of MACE during follow-up
Measured: Throughout the 3 month CR program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized Control Trial including 2 Parallel Groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hatem Hassan Mohammed Maghraby, Assiut University
- Investigators
- Hamdy Shams Eddin Mohammad Taher, MD, Study chair, Assiut UniversityMagdy Ibrahim Aldesowky Mohamed Algowhary, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155928
- Sponsor's protocol ID
- CR on LV Remod in PPCI Pt
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soleimannejad K, Nouzari Y, Ahsani A, Nejatian M, Sayehmiri K. Evaluation of the effect of cardiac rehabilitation on left ventricular diastolic and systolic function and cardiac chamber size in patients undergoing percutaneous coronary intervention. J Tehran Heart Cent. 2014;9(2):54-8.
PubMed 25861319Scalvini S, Zanelli E, Comini L, Dalla Tomba M, Troise G, Febo O, Giordano A. Home-based versus in-hospital cardiac rehabilitation after cardiac surgery: a nonrandomized controlled study. Phys Ther. 2013 Aug;93(8):1073-83. doi: 10.2522/ptj.20120212. Epub 2013 Apr 18.
PubMed 23599353Qi Z, Zheng Y, Chan JSK, Tse G, Liu T. Exercise-based cardiac rehabilitation for left ventricular function in patients with heart failure: A systematic review and meta-analysis. Curr Probl Cardiol. 2024 Feb;49(2):102210. doi: 10.1016/j.cpcardiol.2023.102210. Epub 2023 Nov 20.
PubMed 37993005Mahmoud, S. Y. Z., Mohamed Ahmed; Alamin, Ali Mohamed; Yassin, Ibrahim Abdel-Fattah; and Hassaan, Ahmad Mohammad (2024) (2024). Effect of Cardiac Rehabilitation on Left Ventricular Remodeling After Acute Anterior Wall ST Segment Elevation Myocardial Infarction Treated by Late PCI Using 3D Echocardiography: A Randomized Study. Al-Azhar International Medical Journal, 33. https://doi.org/DOI: https://doi.org/10.58675/2682-339X.2235
Dubach P, Myers J, Dziekan G, Goebbels U, Reinhart W, Vogt P, Ratti R, Muller P, Miettunen R, Buser P. Effect of exercise training on myocardial remodeling in patients with reduced left ventricular function after myocardial infarction: application of magnetic resonance imaging. Circulation. 1997 Apr 15;95(8):2060-7. doi: 10.1161/01.cir.95.8.2060.
PubMed 9133516Ahmed Galal A. Fattah Fahmy MD , Gamal Abdel Hady MD , M. H. H., MD , K. M. M. M. a., & MD, M. E. B. (2021). Continuous Moderate Exercise Influence on Cardiac Remodeling in Patients Underwent Percutaneous Coronary Intervention. SciVision.