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

NCT02932696 | Completed

• 1 other identifier: NIMAO/2016-06/AD-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (62)

• 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

Study Arms (2)

Exercise training

EXPERIMENTAL

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

No exercise training

NO INTERVENTION

Patients in this arm were encouraged to participate in an exercise training program, and they refused to do so.

Interventions

Cardiac training program OTHER

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.

Exercise training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is simultaneously participating in (or has participated in the past 3 months) another interventional 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Arnaud Dupeyron, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 13, 2016
• Study Start: May 5, 2017
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Locations

FR (1)