Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound

Study Overview
=================
Brief Summary
-----------------
The main goal of our project is to study and describe the effect of exercise training on systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial infarction. Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise training will be improved compared to baseline values as well as compared to values in a no-training group. Should this hypothesis prove true, it would help explain the improvements in functional capacity observed during the post-infarction period and after exercise training.

Official Title
-----------------
Post Infarction Exercise Training Effects on Systolic and Diastolic Myocardial Function Assessed by 2D Strain Ultrasound

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Cardiac training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 4 months of follow-up The patient had a first myocardial infarction episode (within the past 3 months) requiring medical treatment or revascularisation (e.g. balloon angioplasty) or aortocoronary bypass Exclusion Criteria: The patient is simultaneously participating in (or has participated in the past 3 months) another interventional study The patient is in an exclusion period determined by a previous study The patient is under judicial protection or under guardianship It is impossible to correctly inform the patient or the patient refuses to sign the consent The patient is pregnant, parturient, or breastfeeding Contra indication for exercise training Valve prosthesis Severe valvular disease Pacemaker Heart transplant Non sinus rhythm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training<br>Patients in this arm were encouraged to participate in an exercise training program, and they accepted to do so. Intervention: Cardiac training program | Other: Cardiac training program<br>* This program takes place at the Cardiovascular Rehabilitation Department at the Nîmes University Hospital and includes a combination of various physical activities: treadmill, exercise bike, rower, aerobics, gymnastics, serious games, swimming. The program begins approximately within 3 months after myocardial infarction and consists of 20 consecutive days of training. The main physical activity is aerobic interval training (AIT). 30-minute AIT sessions will occur 5x per week for 4 weeks. 1 AIT session includes a warm up for 8 minutes to reach a heart rate during exercise corresponding to 20 to 30% of maximum aerobic power determined during the initial effort test. Then interval training occurs with 4x2 min of high intensity effort (heart rate during exercise corresponding to 80% of maximum aerobic power) alternating with 2 min of active recovery at 20-30% of maximum aerobic power. Then recovery for 8 minutes.<br>|
| No Intervention: No exercise training<br>Patients in this arm were encouraged to participate in an exercise training program, and they refused to do so. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % global longitudinal strain of the left ventricle |  | within 3 months post infarction = T0 (baseline) | 
| The % global longitudinal strain of the left ventricle |  | 5 weeks | 
| The % global longitudinal strain of the left ventricle |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal oxygen consumption (VO2max; mL/min/kg) |  | within 3 months post infarction = T0 (baseline) | 
| maximal oxygen consumption (VO2max; mL/min/kg) |  | T0 + 5 weeks | 
| maximal oxygen consumption (VO2max; mL/min/kg) |  | T0 + 3 months | 
| maximum aerobic power (watts) |  | within 3 months post infarction = T0 (baseline) | 
| maximum aerobic power (watts) |  | T0 + 5 weeks | 
| maximum aerobic power (watts) |  | T0 + 3 months | 
| First ventilatory threshold (mL/min/kg) |  | within 3 months post infarction = T0 (baseline) | 
| First ventilatory threshold (mL/min/kg) |  | T0 + 5 weeks | 
| First ventilatory threshold (mL/min/kg) |  | T0 + 3 months | 
| left ventricle longitudinal systolic strain rate |  | within 3 months post infarction = T0 (baseline) | 
| left ventricle longitudinal systolic strain rate |  | T0 + 5 weeks | 
| left ventricle longitudinal systolic strain rate |  | T0 + 3 months | 
| left ventricle longitudinal diastolic strain rate |  | within 3 months post infarction = T0 (baseline) | 
| left ventricle longitudinal diastolic strain rate |  | T0 + 5 weeks | 
| left ventricle longitudinal diastolic strain rate |  | T0 + 3 months | 
| % radial systolic strain |  | within 3 months post infarction = T0 (baseline) | 
| % radial systolic strain |  | T0 + 5 weeks | 
| % radial systolic strain |  | T0 + 3 months | 
| % radial diastolic strain |  | within 3 months post infarction = T0 (baseline) | 
| % radial diastolic strain |  | T0 + 5 weeks | 
| % radial diastolic strain |  | T0 + 3 months | 
| % circumferential systolic strain |  | within 3 months post infarction = T0 (baseline) | 
| % circumferential systolic strain |  | T0 + 5 weeks | 
| % circumferential systolic strain |  | T0 + 3 months | 
| % circumferential diastolic strain |  | within 3 months post infarction = T0 (baseline) | 
| % circumferential diastolic strain |  | T0 + 5 weeks | 
| % circumferential diastolic strain |  | T0 + 3 months | 
| Radial systolic strain rate |  | within 3 months post infarction = T0 (baseline) | 
| Radial systolic strain rate |  | T0 + 5 weeks | 
| Radial systolic strain rate |  | T0 + 3 months | 
| Radial diastolic strain rate |  | within 3 months post infarction = T0 (baseline) | 
| Radial diastolic strain rate |  | T0 + 5 weeks | 
| Radial diastolic strain rate |  | T0 + 3 months | 
| Circumferential systolic strain rate |  | within 3 months post infarction = T0 (baseline) | 
| Circumferential systolic strain rate |  | T0 + 5 weeks | 
| Circumferential systolic strain rate |  | T0 + 3 months | 
| Circumferential diastolic strain rate |  | within 3 months post infarction = T0 (baseline) | 
| Circumferential diastolic strain rate |  | T0 + 5 weeks | 
| Circumferential diastolic strain rate |  | T0 + 3 months | 
| Telediastolic volume (mL) |  | within 3 months post infarction = T0 (baseline) | 
| Telesystolic volume (mL) |  | T0 + 5 weeks | 
| Telesystolic volume (mL) |  | T0 + 3 months | 
| Telediastolic volume (mL) |  | T0 + 5 weeks | 
| Telediastolic volume (mL) |  | T0 + 3 months | 
| Left ventricle mass (g/m^2) |  | within 3 months post infarction = T0 (baseline) | 
| Left ventricle mass (g/m^2) |  | T0 + 5 weeks | 
| Left ventricle mass (g/m^2) |  | T0 + 3 months | 
| Ejection fraction of the left ventricle |  | within 3 months post infarction = T0 (baseline) | 
| Ejection fraction of the left ventricle |  | T0 + 5 weeks | 
| Ejection fraction of the left ventricle |  | T0 + 3 months | 
| S' wave velocity (cm/s) |  | within 3 months post infarction = T0 (baseline) | 
| S' wave velocity (cm/s) |  | T0 + 5 weeks | 
| S' wave velocity (cm/s) |  | T0 + 3 months | 
| E' wave velocity (cm/s) |  | within 3 months post infarction = T0 (baseline) | 
| E' wave velocity (cm/s) |  | T0 + 5 weeks | 
| E' wave velocity (cm/s) |  | T0 + 3 months | 
| A' wave velocity (cm/s) |  | within 3 months post infarction = T0 (baseline) | 
| A' wave velocity (cm/s) |  | T0 + 5 weeks | 
| A' wave velocity (cm/s) |  | T0 + 3 months | 
| The E/A ratio |  | within 3 months post infarction = T0 (baseline) | 
| The E/A ratio |  | T0 + 5 weeks | 
| The E/A ratio |  | T0 + 3 months |