Montreal Heart Attack Readjustment Trial (M-HART)

Cardiovascular Diseases Clinical Trial

Official title:

Montreal Heart Attack Readjustment Trial (M-HART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000533
• Other study ID #: 76
• Secondary ID: R01HL047330
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: December 28, 2015
• Start date: February 1992
• Est. completion date: December 1996

Study information

• Verified date: March 2005
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To examine the impact of a monitoring and social support intervention upon survival of myocardial infarction patients.

Description:

BACKGROUND:

Despite evidence that social support and various aspects of negative affect may influence prognosis after a myocardial infarction, the impact of psychosocial supportive interventions had not been demonstrated. Further, little was known about the impact of psychosocial and/or interventions among women patients. Previous work by Nancy Frasure-Smith and colleagues suggested that a one-year post-myocardial infarction program of monthly telephone monitoring of psychological stress symptoms, coupled with home nursing visits for patients reporting high stress levels, had an impact on one-year cardiac mortality and long-term myocardial infarction recurrences among men. However, methodological difficulties prevented drawing firm conclusions. A trial which corrected for these difficulties was conducted involving 948 post-myocardial infarction patients. However, the project was too small to study enough patients to assess program impact separately for men and women. The trial was supported by Canadian sources. The NHLBI supplemented the study in order to expand the sample size from 948 patients to 1,376 patients to allow gender analysis.

DESIGN NARRATIVE:

Randomized, with a multi-hospital design. At the time of discharge from the hospital following a documented myocardial infarction, patients were randomized to treatment and control groups. The control group received usual care from their physicians. In addition to usual care, treatment patients were phoned monthly and responded to a standardized index of psychological symptoms of stress. Those with high stress levels received home nursing visits to reduce their stress. Patients in both groups took part in three interviews: in the hospital, at three months, and at one year post-discharge. Interviews assessed depression, anxiety, anger, self-perceived stress, social support, medication compliance, and cardiac risk factors. Salivary cortisol, a physiological indicator of stress, was assessed on the evening following each interview. Indicators of residual myocardial infarction, ischemia, and arrhythmias were obtained from hospital charts. Outcome data were obtained from hospital charts, death certificates, and Quebec Medicare data and were blindly classified by study cardiologists.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years
• Eligibility: Men and women myocardial infarction patients.

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Behavioral:
• social support

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McGill University	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Frasure-Smith N, Lespérance F, Prince RH, Verrier P, Garber RA, Juneau M, Wolfson C, Bourassa MG. Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction. Lancet. 1997 Aug 16;350(9076):473-9. — View Citation

Frasure-Smith N. The Montreal Heart Attack Readjustment Trial. J Cardiopulm Rehabil. 1995 Mar-Apr;15(2):103-6. — View Citation