Early Versus Standard Access Cardiac Rehabilitation to Counter Ventricular Remodeling Post-MI (EVADE)

NCT03534817 | Suspended DMC

• 1 other identifier: USaskatchewan-EVADE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND: Cardiac rehabilitation (CR) is an outpatient chronic disease management program delivering secondary prevention, which is proven to reduce morbidity and mortality. The Canadian Cardiovascular Society Access to Care working group recommends patients access CR "preferably" within 2-7 days following percutaneous intervention for myocardial infarction (MI), but that 30-60 days is "acceptable". Despite these benchmarks, in practice patients access CR up to 90 days post-treatment in Canada. This is disconcerting given the detrimental impacts of delayed access to CR. These include ventricular remodeling (i.e., ventricular enlargement and reduced pump function), lower CR use, less post-CR exercise, among others. Accordingly, EVADE will be the first randomized controlled trial (RCT) to test the effects of early access CR (1-week post-discharge to first CR visit) compared to standard access CR (7-weeks post-discharge to first CR visit) in ameliorating these concerns. AIMS \& HYPOTHESIS: The primary aim is to compare ventricular remodeling as defined by the change in end-systolic volume at 1-year in participants randomized to early versus standard access CR. The secondary aims are: (1) to compare post-CR exercise adherence by accelerometry, exercise capacity by 6-minute walk test distance, and health-related quality of life (HRQL) at 1-year in participants randomized to early versus standard access CR; (2) to compare CR program session attendance in participants randomized to early versus standard access CR; and (3) to assess biomarkers of ventricular remodeling in participants randomized to early versus standard access CR. The final aims are to explore more immediate health benefits associated with early versus standard access CR. Accordingly, at 6 months following hospital discharge the investigators will measure end-systolic volume, exercise adherence, exercise capacity, biomarkers of ventricular remodeling, and HRQL. The investigators will also explore hospitalization for any cause of death at 1 year in order to inform future research. The overall hypothesis is that early access CR will be associated with less ventricular remodeling, increased CR attendance and post-CR exercise adherence, increased exercise capacity, and greater HRQL. DESIGN: EVADE will be a two-centre, 2 parallel-arm, single-blinded RCT. Participants will be recruited through coronary care units following treatment for MI from the Royal University Hospital in Saskatoon, Saskatchewan and the University of Alberta Hospital in Edmonton. The University of Alberta Research Electronic Data Capture (REDCap) online database will randomize (1:1) participants (allocation concealed). A total of 60 participants will be enrolled: 30 participants will each be allocated to early access and standard access CR. IMPACT: In the first prospective multicentre trial of its kind, EVADE will test an innovative post-MI rehabilitation strategy that has the potential to demonstrate the superior benefits of early access CR for attenuating ventricular remodeling, and increasing CR attendance, post-CR exercise adherence, exercise capacity, and HRQL. The results from EVADE would encourage the Canadian CR community to consider early access CR to further enhance readily available and existing CR programs. The knowledge gained from EVADE will inform clinical decision-making practices, influence future CR guidelines and policy, and will contribute to the ongoing goal of improving efficiency and effectiveness of the Canadian health care system.

Conditions

Myocardial Infarction

Keywords

Cardiac Rehabilitation; Early Access Cardiac Rehabilitation; Cardiac Rehabilitation Adherence; Myocardial Infarction; Ventricular Remodeling

Outcome Measures

Primary Outcomes (1)

• Change in ventricular remodeling from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).

  End-diastolic volume (in milliliters) will be the primary marker of ventricular remodeling, and will be measured using clinical-grade cardiac magnetic resonance imaging (MRI).

  A repeated measures approach will be taken for the primary outcome: before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI.

Secondary Outcomes (19)

• Change in end-systolic volume (in milliliters) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).

  Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI

• Change in stroke volume (in milliliters) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).

  Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI

• Change in ejection fraction (percentage) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).

  Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI

• Change in MI-related cardiac damage from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).

  Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI

• Change in metalloproteinase-9 (MMP-9) from in-hospital following MI to 6-months (immediate change) and 12-months post-MI (long-term change).

  Before hospital discharge following MI; at 6 months post-MI; at 12 months post-MI

Other Outcomes (5)

• Infarction Type

  Before hospital discharge

• Medications

  Before hospital discharge and 12 months post-MI

• Medical History

  Before hospital discharge and 12-months post-MI

Study Arms (2)

Early Access CR

EXPERIMENTAL

Participants begin cardiac rehabilitation (CR) after 1-week following discharge post-MI.

Behavioral: Early Access CR

Standard Access CR

NO INTERVENTION

Participants begin CR after 7-weeks following discharge post-MI, similar to the average Canadian wait time.

Interventions

Early Access CR BEHAVIORAL

Participants in the Early Access CR group will begin CR within 1-week post-hospital discharge following their MI, as opposed to Standard Access CR group which begins 7-weeks post-hospital discharge, and the Canadian average (10-14 weeks post-hospital discharge). No further intervention or differentiation between groups is applied; the actual CR program is standardized between groups, and follows the guidelines regularly practiced by the institution.

Early Access CR

Eligibility Criteria

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

You may qualify if:

• have a cardiologist-diagnosed non ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI) identified as low risk based on the Global Registry for Acute Coronary Events (GRACE) risk score;
• have angiographic evidence of revascularization of the infarct-related artery that is defined as ≥80% patency;
• have an ejection fraction ≥35% (to exclude patients needing a cardioverter defibrillator) and \<50% (consistent with impaired heart pump function);
• reside within 100 km (1 hour travel time) of Saskatoon/Edmonton city limits;
• have been approved to attend CR by their attending physician.

You may not qualify if:

• have been hospitalized for a previous MI
• have a condition that precludes walk testing;
• have a contra-indication for cardiac MRI (i.e., pacemaker, pregnancy);
• index hospitalization \>10 days;
• undergo coronary artery bypass grafting;
• does not undergo coronary angiography.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Heart and Stroke Foundation of Canada: collaborator
• Saskatchewan Health Research Foundation: collaborator
• Royal University Hospital Foundation: collaborator
• University of Alberta: collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Myocardial Infarction; Ventricular Remodeling

Condition Hierarchy (Ancestors)

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

Study Officials

• David (Ian) Paterson, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, College of Kinesiology

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: May 23, 2018
• Study Start: January 8, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)