Myocardial InfarctionDIRECTNCT02508727
Myocardial Deformation in Real-time 3D Ultrasound. Normal Values in Adults and Validation Against the Tagged MRI
A study testing MRI and 3D cardiac ultrasound in people with Myocardial Infarction, run by University Hospital, Caen at 1 site in France.
Trial summary
Cardiac exploration almost systematically requires the acquisition and / or calculating function indices. The ejection fraction (LVEF) is probably based index most widely used in all cardiac exploration methods. This relatively universal overall index has very many qualities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- MRI and 3D cardiac ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who signed the consent form
- Beneficiaries of the health security system
- No known cardiovascular disease to healthy subjects or patient having a previous heart attack or less proved by cardiac MRI or viability of myocardial scintigraphy performed before. The infarct zone is defined as the area of delayed enhancement cardiac MRI signal in 10-15 minutes after gadolinium injection.
Who cannot join
- Age <18 years
- Adult guardianship
- Contraindications to MRI: metallic implants, pacemaker, implantable defibrillator, claustrophobia
- For patients only: Contraindication to Dotarem (renal failure with creatinine clearance <30 ml / min / 1.73m2 according to MDRD formula, known allergy to gadolinium salts)
- Pregnant and or lactating
- Recent acute coronary syndrome (<6 weeks)
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- Ventricular arrhythmias and supra ventricular significant
- Heart failure stage III-IV NYHA
- Unbalanced severe hypertension (BP> 160/110 mmHg)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, Basse Normandie, 14033
Eric Saloux, MD, 0231065395
Eric saloux, MD
About this study
Cardiac exploration almost systematically requires the acquisition and / or calculating function indices. The ejection fraction (LVEF) is probably based index most widely used in all cardiac exploration methods. This relatively universal overall index has very many qualities. LVEF is widely used in clinical practice through the exploration and monitoring of all heart disease.
Current progress in the management of various cardiomyopathies pass through the detection of early attacks. This testing often takes place upstream changes in LVEF that remains long normal or normalized. Sensitive indicators capable of detecting early abnormalities of regional functions are essential in addition to conventional echocardiography. Various studies have shown the contribution of these new markers in early detection of abnormalities of the cardiac function. The most widely used indicator in these studies because of its high sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler however has limitations in particular its dependence on the incident angle, which makes it impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.
Read more
A new way of exploring the regional function of the heart, speckle tracking, can analyze heart deformations along the principal axes of the heart. The advantage of this technique has been shown in various pathological situations. Currently, this technique is mostly used in longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated software is confidential dissemination and unvalidated.
The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In the 90s, studies have demonstrated the feasibility of this technique, the ability to access all of the myocardial deformation in space and to define normal values. The cost of the procedure, duration, limited accessibility and post-processing very time consuming limited the scope of the clinical benefits of this modality.
Echocardiography has major advantages over MRI, particularly its high availability, low cost and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is a new opportunity that it is essential to validate.
The main purpose of the study is to compare the strain values obtained 3D ultrasound to those obtained by MRI tagged in a control group and a group of subjects with an anterior infarction sequela.
- Conditions
- Myocardial Infarction
- Being tested
- MRI, 3D cardiac ultrasound
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
3D cardiac ultrasoundOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | Healthy volunteers Receives: Other: MRI; Other: 3D cardiac ultrasound |
| Subjects with an anterior myocardial infarction sequela | Other | Subjects with an anterior myocardial infarction sequela Receives: Other: MRI; Other: 3D cardiac ultrasound |
| Subjects with lower myocardial infarction sequelae | Other | Subjects with lower myocardial infarction sequelae Receives: Other: MRI; Other: 3D cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strain value
Comparison beetween arms and taage MRI and 3D cardiac echography
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startMar 2012
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508727
- Sponsor's protocol ID
- 10-156
- Acronym
- DIRECT
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Deformation in Real-time 3D Ultrasound. Normal Values in Adults and Validation Against the Tagged MRI
- ClinicalTrials.gov ID
- NCT02508727
- Acronym / sponsor ID
- DIRECT / 10-156
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (estimated)
- First posted
- 27 Jul 2015 (estimated)
- 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.
Cardiac exploration almost systematically requires the acquisition and / or calculating function indices. The ejection fraction (LVEF) is probably based index most widely used in all cardiac exploration methods. This relatively universal overall index has very many qualities. LVEF is widely used in clinical practice through the exploration and monitoring of all heart disease.
Current progress in the management of various cardiomyopathies pass through the detection of early attacks. This testing often takes place upstream changes in LVEF that remains long normal or normalized. Sensitive indicators capable of detecting early abnormalities of regional functions are essential in addition to conventional echocardiography. Various studies have shown the contribution of these new markers in early detection of abnormalities of the cardiac function. The most widely used indicator in these studies because of its high sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler however has limitations in particular its dependence on the incident angle, which makes it impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.
A new way of exploring the regional function of the heart, speckle tracking, can analyze heart deformations along the principal axes of the heart. The advantage of this technique has been shown in various pathological situations. Currently, this technique is mostly used in longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated software is confidential dissemination and unvalidated.
The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In the 90s, studies have demonstrated the feasibility of this technique, the ability to access all of the myocardial deformation in space and to define normal values. The cost of the procedure, duration, limited accessibility and post-processing very time consuming limited the scope of the clinical benefits of this modality.
Echocardiography has major advantages over MRI, particularly its high availability, low cost and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is a new opportunity that it is essential to validate.
The main purpose of the study is to compare the strain values obtained 3D ultrasound to those obtained by MRI tagged in a control group and a group of subjects with an anterior infarction sequela.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: MRI, Other: 3D cardiac ultrasoundHealthy volunteers |
| Subjects with an anterior myocardial infarction sequela | Other | Other: MRI, Other: 3D cardiac ultrasoundSubjects with an anterior myocardial infarction sequela |
| Subjects with lower myocardial infarction sequelae | Other | Other: MRI, Other: 3D cardiac ultrasoundSubjects with lower myocardial infarction sequelae |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who signed the consent form
- Beneficiaries of the health security system
- No known cardiovascular disease to healthy subjects or patient having a previous heart attack or less proved by cardiac MRI or viability of myocardial scintigraphy performed before. The infarct zone is defined as the area of delayed enhancement cardiac MRI signal in 10-15 minutes after gadolinium injection.
Key exclusion criteria (9 listed)
- Age <18 years
- Adult guardianship
- Contraindications to MRI: metallic implants, pacemaker, implantable defibrillator, claustrophobia
- For patients only: Contraindication to Dotarem (renal failure with creatinine clearance <30 ml / min / 1.73m2 according to MDRD formula, known allergy to gadolinium salts)
- Pregnant and or lactating
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 |
|---|---|---|
| MRI | Other | Healthy volunteers, Subjects with an anterior myocardial infarction sequela, Subjects with lower myocardial infarction sequelae |
| 3D cardiac ultrasound | Other | Healthy volunteers, Subjects with an anterior myocardial infarction sequela, Subjects with lower myocardial infarction sequelae |
Primary outcome
Strain value
Time frame: baseline
Comparison beetween arms and taage MRI and 3D cardiac echography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and 3D cardiac ultrasound in people with Myocardial Infarction, run by University Hospital, Caen at 1 site 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strain value (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2015.