NCT02048696

Brief Summary

Patients who have suffered a heart attack are at risk of developing worsening heart function and heart failure. Exercise training has a beneficial effect on heart function and prevents heart failure. The aim of the current study is to investigate the effect of exercise training on heart function in patients who have suffered a heart attack.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

January 22, 2014

Last Update Submit

October 17, 2018

Conditions

Keywords

Exercise trainingHigh intensity interval trainingleft ventricular systolic functionG-protein related kinase 2heart failuremyocardial infarctioncoronary artery diseasebeta adrenergic receptor

Outcome Measures

Primary Outcomes (1)

  • Lymphocyte GRK2 mRNA level

    change in lymphocyte GRK2 mRNA levels

    at baseline and following 12 weeks exercise training intervention

Secondary Outcomes (9)

  • Left ventricular systolic function

    at baseline and following 12 weeks exercise training intervention

  • Left ventricular dimensions

    at baseline and following 12 weeks exercise training intervention

  • Plasma epinephrine

    at baseline and following 12 weeks exercise training intervention

  • heart rate variability

    at baseline and following 12 weeks exercise training intervention

  • exercise capacity (VO2max)

    at baseline and following 12 weeks exercise training intervention

  • +4 more secondary outcomes

Other Outcomes (2)

  • Fasting glucose

    at baseline and following 12 weeks exercise training intervention

  • serum lipids

    at baseline and following 12 weeks exercise training intervention

Study Arms (2)

Exercise training

EXPERIMENTAL

Secondary prevention and cardiac rehabilitation clinic of the Montreal Heart Institute. Subjects will undergo twice weekly exercise training with high intensity interval training for a period of 12 weeks.

Other: Secondary prevention and cardiac rehabilitation clinic

control

NO INTERVENTION

Individuals in this group are offered current ACC/AHA recommendations on physical activity in patients post-myocardial infarction.

Interventions

Secondary prevention and cardiac rehabilitation clinic of the Montreal Heart Institute. Subjects will undergo twice weekly exercise training with high intensity interval training for a period of 12 weeks.

Exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute myocardial infarction
  • Complete revascularization: no residual major epicardial coronary artery coronary stenosis ≥ 70%; no residual left main coronary stenosis ≥ 40%.
  • Stage A-C heart failure, New York Heart Association class I-III.
  • Stable dose of medications during the 4 weeks prior to enrolment.
  • Able to perform a maximal cardiopulmonary stress test.
  • Capacity and willingness to provide sign informed consent.

You may not qualify if:

  • Pregnant
  • Coronary artery bypass surgery: patients post coronary artery bypass graft exhibit wall motion abnormalities that may interfere with speckle tracking analysis.
  • Incomplete revascularization with major epicardial coronary artery (left anterior descending, circumflex, or right coronary) stenosis ≥ 70%.
  • Myocardial necrosis in the absence of significant flow limiting coronary artery stenosis or thrombosis, with the exception of documented STEMI and successful thrombolytic therapy resulting on no significant residual epicardial coronary artery stenosis.
  • Significant valvular disease that is greater than moderate in severity
  • History of non-ischemic cardiomyopathy (dilated, restrictive, infiltrative cardiomyopathy, hypertrophic, LV non compaction, or Takotsubo cardiomyopathy)
  • Significant resting ECG abnormalities that preclude accurate speckle tracking.
  • Paced rhythm.
  • left bundle branch block
  • Atrial arrhythmias (ex. persistent/permanent atrial fibrillation, atrial flutter).
  • Frequent ventricular ectopics
  • Significant ventricular arrhythmias (non-sustained ventricular tachycardia or syncope).
  • New York Heart Association class IIIb - IV symptoms.
  • Severe LV systolic dysfunction (Ejection fraction ≤ 30%)
  • Active decompensated heart failure with orthopnea or paroxysmal nocturnal dyspnea.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for preventive medicine and physical activity of the Montreal Heart Institute (Centre ÉPIC)

Montreal, Quebec, H1T 1N6, Canada

Location

Related Publications (2)

  • Trachsel LD, Boidin M, Henri C, Fortier A, Lalonge J, Juneau M, Nigam A, Gayda M. Women and men with coronary heart disease respond similarly to different aerobic exercise training modalities: a pooled analysis of prospective randomized trials. Appl Physiol Nutr Metab. 2021 May;46(5):417-425. doi: 10.1139/apnm-2020-0650. Epub 2020 Oct 23.

  • Trachsel LD, Nigam A, Fortier A, Lalonge J, Juneau M, Gayda M. Moderate-intensity continuous exercise is superior to high-intensity interval training in the proportion of VO2peak responders after ACS. Rev Esp Cardiol (Engl Ed). 2020 Sep;73(9):725-733. doi: 10.1016/j.rec.2019.09.013. Epub 2019 Dec 16. English, Spanish.

MeSH Terms

Conditions

Myocardial InfarctionHeart FailureCoronary Artery Disease

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Anil Nigam, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 29, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

October 16, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations