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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02932696
Date of registration:	12/10/2016
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Universitaire de Nimes
Public title:	Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound TrainStrain
Scientific title:	Post Infarction Exercise Training Effects on Systolic and Diastolic Myocardial Function Assessed by 2D Strain Ultrasound
Date of first enrolment:	May 5, 2017
Target sample size:	65
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02932696
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	Arnaud Dupeyron, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myocardial Infarction

Intervention(s)

Other: Cardiac training program

Primary Outcome(s)

The % global longitudinal strain of the left ventricle [Time Frame: within 3 months post infarction = T0 (baseline)]

The % global longitudinal strain of the left ventricle [Time Frame: 3 months]

The % global longitudinal strain of the left ventricle [Time Frame: 5 weeks]

Secondary Outcome(s)

% circumferential systolic strain [Time Frame: T0 + 5 weeks]

% radial diastolic strain [Time Frame: within 3 months post infarction = T0 (baseline)]

left ventricle longitudinal diastolic strain rate [Time Frame: T0 + 3 months]

Radial systolic strain rate [Time Frame: T0 + 3 months]

Telediastolic volume (mL) [Time Frame: T0 + 3 months]

Telesystolic volume (mL) [Time Frame: T0 + 3 months]

Circumferential systolic strain rate [Time Frame: T0 + 5 weeks]

E' wave velocity (cm/s) [Time Frame: T0 + 3 months]

Left ventricle mass (g/m^2) [Time Frame: T0 + 3 months]

maximal oxygen consumption (VO2max; mL/min/kg) [Time Frame: T0 + 5 weeks]

maximum aerobic power (watts) [Time Frame: T0 + 3 months]

Radial diastolic strain rate [Time Frame: T0 + 5 weeks]

The E/A ratio [Time Frame: T0 + 3 months]

% radial systolic strain [Time Frame: T0 + 5 weeks]

A' wave velocity (cm/s) [Time Frame: within 3 months post infarction = T0 (baseline)]

% circumferential systolic strain [Time Frame: within 3 months post infarction = T0 (baseline)]

E' wave velocity (cm/s) [Time Frame: within 3 months post infarction = T0 (baseline)]

% circumferential diastolic strain [Time Frame: within 3 months post infarction = T0 (baseline)]

% radial diastolic strain [Time Frame: T0 + 5 weeks]

E' wave velocity (cm/s) [Time Frame: T0 + 5 weeks]

First ventilatory threshold (mL/min/kg) [Time Frame: T0 + 3 months]

Ejection fraction of the left ventricle [Time Frame: T0 + 3 months]

left ventricle longitudinal diastolic strain rate [Time Frame: T0 + 5 weeks]

A' wave velocity (cm/s) [Time Frame: T0 + 5 weeks]

Circumferential diastolic strain rate [Time Frame: T0 + 3 months]

% circumferential systolic strain [Time Frame: T0 + 3 months]

% radial diastolic strain [Time Frame: T0 + 3 months]

left ventricle longitudinal systolic strain rate [Time Frame: T0 + 5 weeks]

Radial systolic strain rate [Time Frame: T0 + 5 weeks]

Ejection fraction of the left ventricle [Time Frame: T0 + 5 weeks]

left ventricle longitudinal diastolic strain rate [Time Frame: within 3 months post infarction = T0 (baseline)]

Circumferential diastolic strain rate [Time Frame: T0 + 5 weeks]

Circumferential systolic strain rate [Time Frame: T0 + 3 months]

S' wave velocity (cm/s) [Time Frame: T0 + 3 months]

The E/A ratio [Time Frame: T0 + 5 weeks]

left ventricle longitudinal systolic strain rate [Time Frame: T0 + 3 months]

Radial systolic strain rate [Time Frame: within 3 months post infarction = T0 (baseline)]

% circumferential diastolic strain [Time Frame: T0 + 5 weeks]

% radial systolic strain [Time Frame: within 3 months post infarction = T0 (baseline)]

maximal oxygen consumption (VO2max; mL/min/kg) [Time Frame: within 3 months post infarction = T0 (baseline)]

Telediastolic volume (mL) [Time Frame: within 3 months post infarction = T0 (baseline)]

% circumferential diastolic strain [Time Frame: T0 + 3 months]

% radial systolic strain [Time Frame: T0 + 3 months]

Radial diastolic strain rate [Time Frame: within 3 months post infarction = T0 (baseline)]

The E/A ratio [Time Frame: within 3 months post infarction = T0 (baseline)]

A' wave velocity (cm/s) [Time Frame: T0 + 3 months]

Ejection fraction of the left ventricle [Time Frame: within 3 months post infarction = T0 (baseline)]

S' wave velocity (cm/s) [Time Frame: T0 + 5 weeks]

First ventilatory threshold (mL/min/kg) [Time Frame: T0 + 5 weeks]

First ventilatory threshold (mL/min/kg) [Time Frame: within 3 months post infarction = T0 (baseline)]

Left ventricle mass (g/m^2) [Time Frame: T0 + 5 weeks]

Left ventricle mass (g/m^2) [Time Frame: within 3 months post infarction = T0 (baseline)]

maximum aerobic power (watts) [Time Frame: T0 + 5 weeks]

maximum aerobic power (watts) [Time Frame: within 3 months post infarction = T0 (baseline)]

Radial diastolic strain rate [Time Frame: T0 + 3 months]

S' wave velocity (cm/s) [Time Frame: within 3 months post infarction = T0 (baseline)]

Circumferential diastolic strain rate [Time Frame: within 3 months post infarction = T0 (baseline)]

Circumferential systolic strain rate [Time Frame: within 3 months post infarction = T0 (baseline)]

left ventricle longitudinal systolic strain rate [Time Frame: within 3 months post infarction = T0 (baseline)]

maximal oxygen consumption (VO2max; mL/min/kg) [Time Frame: T0 + 3 months]

Telediastolic volume (mL) [Time Frame: T0 + 5 weeks]

Telesystolic volume (mL) [Time Frame: T0 + 5 weeks]

Secondary ID(s)

NIMAO/2016-06/AD-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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