Montreal Heart Attack Readjustment Trial - M-HART

Description:

The Montreal Heart Attack Readjustment Trial (M-HART) was a randomized controlled trial designed to investigate whether a nursing intervention program to reduce psychosocial distress would have an impact on cardiac mortality in patients following myocardial infarction (MI).

Hypothesis:

Patients receiving a one-year program of monthly monitoring of psychosocial distress symptoms combined with home-nursing visits would be less likely to die from cardiac causes during the first year after an MI.

Study Design

Study Design:

Patients Screened: 2,483
Patients Enrolled: 1,376
Mean Follow Up: 1 year
Mean Patient Age: mean of 59 with S.D. 11.5
Female: 34

Patient Populations:

Patients with acute MI not related to a coronary procedure. Diagnosis of MI was based on symptoms, and on enzyme and electrocardiographic criteria. Q-wave MI was defined as new pathological Q waves combined with either symptom criteria (typical chest pain of duration ≥30 minutes) or high serum enzyme concentrations (total creatine phosphokinase 2x upper limit of normal or total creatine kinase above the upper limit with MB ≥5% of total). Non-Q-wave MI was defined as high serum enzyme concentrations plus either ischemic ST-T changes or symptom criteria.

Exclusions:

Other life-threatening conditions; residence more than 20 miles from any study hospital; no telephone; deafness; cognitive impairment; inability to speak English or French; refusal by the patient’s physician; and participation in other randomized trials. In addition, owing to the use of the terms MI and heart attack in consent forms and questionnaires, patients who met the study criteria for MI but had not been given an MI diagnosis by their physicians by the time of interview were also excluded.

Primary Endpoints:

One-year cardiac mortality

Secondary Endpoints:

All-cause mortality; recurrence of MI; cause of death; postdischarge admissions for revascularization; and changes over one year in symptoms of depression and anxiety

Drug/Procedures Used:

Phone calls were made by a research assistant one week after discharge, and then every month for one year, assessing symptoms of psychosocial distress on a General Health Questionnaire. When a patient had such symptoms or was readmitted to the hospital, a project nurse, in conjunction with a team of nurses and a psychiatrist contacted the patient, arranged monthly home visits, and designed an intervention program of support and further referrals.

Patients randomly assigned to the control group at discharge received usual care from their physicians. They did not receive monthly telephone monitoring or visits from M-HART nurses. However, they were asked to complete follow-up interviews after three and 12 months.

Concomitant Medications:

Standard care

Principal Findings:

A total of 1,376 post-MI patients (903 men and 473 women) were enrolled and were stratified by gender. In general, the compliance with the intervention protocol was good (86.3%), with 100% follow-up data available. In the intervention group, 83% of patients were contacted at least once by a project nurse, with a median time to first contact of 12 days after the index discharge.

The M-HART program had no overall impact on cardiac mortality (odds ratio [OR] 1.44 [0.84-2.48]) or all-cause mortality (OR 1.41 [0.85-2.34]) at one year. In women, there was a trend for increased cardiac mortality (largely due to arrhythmias and MI) in the intervention group (9.4% vs. 5.0%, p=0.06), even after adjusting for differences in baseline characteristics between treatment groups. There was no significant impact upon symptoms of depression and anxiety in either group.

Interpretation:

This trial demonstrates no association between a psychosocial intervention program in post-MI patients and all-cause mortality or cardiac mortality. In fact, there was a troubling trend for the patients in the intervention group (particularly women) for higher cardiac mortality. These results do not support the routine implementation of psychosocial distress screening and home-nursing interventions to treat patients with these symptoms.

References:

Frasure-Smith N, Lesperance F, Prince RH, et al. Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction. Lancet 1997;350:473-9.

Keywords: Depression, Odds Ratio, Myocardial Infarction, Depressive Disorder, Follow-Up Studies, Creatine Kinase, Chest Pain, Electrocardiography, Questionnaires


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