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Trial NCT00000533

Resource URI: http://static.linkedct.org/resource/trials/NCT00000533
linkedct:brief_title Montreal Heart Attack Readjustment Trial (M-HART)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8483>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women myocardial infarction patients.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 1996
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000533
rdfs:label Trial NCT00000533
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000533
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 76
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/42981>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000533>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/49318>
linkedct:reference <http://static.linkedct.org/resource/reference/52837>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date February 1992
linkedct:study_design Educational/Counseling/Training, Placebo Control
linkedct:study_type Interventional
linkedct:summary To examine the impact of a monitoring and social support intervention upon survival of myocardial infarction patients.
rdf:type linkedct:trials
linkedct:verification_date March 2005