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

Myocardial Infarction Clinical Trial

— TrainStrain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932696
• Other study ID #: NIMAO/2016-06/AD-01
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: July 11, 2019

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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