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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: Cardiac training program

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training; 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; 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.
No Intervention: No exercise training; 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	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Arnaud Dupeyron, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): July 11, 2019
• Study Completion (Actual): July 11, 2019

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 24, 2019
• Last Update Submitted That Met QC Criteria: October 23, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: NIMAO/2016-06/AD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No