Clinical trial NCT02932696: Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound
Official title: Post Infarction Exercise Training Effects on Systolic and Diastolic Myocardial Function Assessed by 2D Strain Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The % global longitudinal strain of the left ventricle
timeFrame: within 3 months post infarction = T0 (baseline)
measure: The % global longitudinal strain of the left ventricle
timeFrame: 5 weeks
measure: The % global longitudinal strain of the left ventricle
timeFrame: 3 months
Secondary outcomes:
measure: maximal oxygen consumption (VO2max; mL/min/kg)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: maximal oxygen consumption (VO2max; mL/min/kg)
timeFrame: T0 + 5 weeks
measure: maximal oxygen consumption (VO2max; mL/min/kg)
timeFrame: T0 + 3 months
measure: maximum aerobic power (watts)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: maximum aerobic power (watts)
timeFrame: T0 + 5 weeks
measure: maximum aerobic power (watts)
timeFrame: T0 + 3 months
measure: First ventilatory threshold (mL/min/kg)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: First ventilatory threshold (mL/min/kg)
timeFrame: T0 + 5 weeks
measure: First ventilatory threshold (mL/min/kg)
timeFrame: T0 + 3 months
measure: left ventricle longitudinal systolic strain rate
timeFrame: within 3 months post infarction = T0 (baseline)
measure: left ventricle longitudinal systolic strain rate
timeFrame: T0 + 5 weeks
measure: left ventricle longitudinal systolic strain rate
timeFrame: T0 + 3 months
measure: left ventricle longitudinal diastolic strain rate
timeFrame: within 3 months post infarction = T0 (baseline)
measure: left ventricle longitudinal diastolic strain rate
timeFrame: T0 + 5 weeks
measure: left ventricle longitudinal diastolic strain rate
timeFrame: T0 + 3 months
measure: % radial systolic strain
timeFrame: within 3 months post infarction = T0 (baseline)
measure: % radial systolic strain
timeFrame: T0 + 5 weeks
measure: % radial systolic strain
timeFrame: T0 + 3 months
measure: % radial diastolic strain
timeFrame: within 3 months post infarction = T0 (baseline)
measure: % radial diastolic strain
timeFrame: T0 + 5 weeks
measure: % radial diastolic strain
timeFrame: T0 + 3 months
measure: % circumferential systolic strain
timeFrame: within 3 months post infarction = T0 (baseline)
measure: % circumferential systolic strain
timeFrame: T0 + 5 weeks
measure: % circumferential systolic strain
timeFrame: T0 + 3 months
measure: % circumferential diastolic strain
timeFrame: within 3 months post infarction = T0 (baseline)
measure: % circumferential diastolic strain
timeFrame: T0 + 5 weeks
measure: % circumferential diastolic strain
timeFrame: T0 + 3 months
measure: Radial systolic strain rate
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Radial systolic strain rate
timeFrame: T0 + 5 weeks
measure: Radial systolic strain rate
timeFrame: T0 + 3 months
measure: Radial diastolic strain rate
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Radial diastolic strain rate
timeFrame: T0 + 5 weeks
measure: Radial diastolic strain rate
timeFrame: T0 + 3 months
measure: Circumferential systolic strain rate
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Circumferential systolic strain rate
timeFrame: T0 + 5 weeks
measure: Circumferential systolic strain rate
timeFrame: T0 + 3 months
measure: Circumferential diastolic strain rate
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Circumferential diastolic strain rate
timeFrame: T0 + 5 weeks
measure: Circumferential diastolic strain rate
timeFrame: T0 + 3 months
measure: Telediastolic volume (mL)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Telesystolic volume (mL)
timeFrame: T0 + 5 weeks
measure: Telesystolic volume (mL)
timeFrame: T0 + 3 months
measure: Telediastolic volume (mL)
timeFrame: T0 + 5 weeks
measure: Telediastolic volume (mL)
timeFrame: T0 + 3 months
measure: Left ventricle mass (g/m^2)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Left ventricle mass (g/m^2)
timeFrame: T0 + 5 weeks
measure: Left ventricle mass (g/m^2)
timeFrame: T0 + 3 months
measure: Ejection fraction of the left ventricle
timeFrame: within 3 months post infarction = T0 (baseline)
measure: Ejection fraction of the left ventricle
timeFrame: T0 + 5 weeks
measure: Ejection fraction of the left ventricle
timeFrame: T0 + 3 months
measure: S' wave velocity (cm/s)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: S' wave velocity (cm/s)
timeFrame: T0 + 5 weeks
measure: S' wave velocity (cm/s)
timeFrame: T0 + 3 months
measure: E' wave velocity (cm/s)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: E' wave velocity (cm/s)
timeFrame: T0 + 5 weeks
measure: E' wave velocity (cm/s)
timeFrame: T0 + 3 months
measure: A' wave velocity (cm/s)
timeFrame: within 3 months post infarction = T0 (baseline)
measure: A' wave velocity (cm/s)
timeFrame: T0 + 5 weeks
measure: A' wave velocity (cm/s)
timeFrame: T0 + 3 months
measure: The E/A ratio
timeFrame: within 3 months post infarction = T0 (baseline)
measure: The E/A ratio
timeFrame: T0 + 5 weeks
measure: The E/A ratio
timeFrame: T0 + 3 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: