DESCRIPTION (provided by applicant): The PACEmaker & Beta-Blocker Therapy Post-Myocardial Infarction (PACE-MI) Trial will investigate whether pacemaker facilitated beta blocker therapy decreases the combined endpoint of total mortality plus nonfatal reinfarction in patients who have suffered a myocardial infarction and have bradycardia contraindications to beta blockers. Currently, these patients are not treated with beta blockers due to the likelihood of developing potentially dangerous bradyarrhythmias from treatment. Because beta blockers are highly effective agents in reducing mortality and reinfarction post-myocardial infarction, particularly in high risk subgroups, there has been increasing emphasis on their use. The patients with bradycardia precluding beta blocker therapy could, in theory, be treated with beta blockers if a pacemaker is implanted first to provide backup rate support. As these patients have been routinely excluded from clinical trials, there is no direct data to support such a recommendation. The specific aim of the PACE-MI Trial is to test whether pacemaker facilitated beta blocker therapy after myocardial infarction confers a clinical advantage in this subgroup of patients. This aim will be accomplished in this multicenter clinical trial in which patients within one month of a myocardial infarction who have either bradycardia or heart block contraindications to beta blockers will be randomized to receive either standard therapy (which would not include a beta-blocker as these patients have contraindications) or standard therapy plus a pacemaker and beta-blocker. This specific aim has important implications in that it will: 1) Provide data to support (if the hypothesis is verified) a change in Medicare coverage policy; 2) Provide support for the treatment paradigm of pacemaker facilitated betablocker therapy; 3) Highlight the importance of beta blocker therapy even in the modern era of management of myocardial infarction, particularly in the currently under treated elderly population. The trial primary composite is total mortality plus nonfatal reinfarction. Patients enrolled in the trial will be followed for two years. The sample size will be 1124 patients who will be enrolled in 60 sites.
|Effective start/end date||9/29/06 → 11/30/15|
- National Institutes of Health: $4,554,590.00
- National Institutes of Health: $590,118.00
- National Institutes of Health: $1,300,000.00
- National Institutes of Health: $810,565.00
- National Institutes of Health: $383,500.00