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Heart Rate Variability and Sudden Cardiac Death

The Ability of Several Short-term Measures of RR Variability to Predict Mortality After Myocardial Infarction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00005235
Enrollment
715
Registered
2000-05-26
Start date
1988-12-31
Completion date
1993-09-30
Last updated
2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Disease, Death, Sudden, Cardiac, Heart Diseases, Myocardial Infarction, Ventricular Arrhythmia

Brief summary

To evaluate the ability of heart rate variability to identify myocardial infarction patients at high risk of dying, particularly from sudden cardiac death.

Detailed description

BACKGROUND: Sudden cardiac death usually is caused by malignant ventricular arrhythmias. Malignant ventricular arrhythmias in coronary heart disease are due to an interplay among substrate such as scarred ventricles, triggering events such as spontaneous ventricular arrhythmias, and the autonomic nervous system. Non-invasive methods were needed to evaluate these three components of risk in order to develop comprehensive detection and prevention programs. Non-invasive screening tests for the arrhythmogenic substrate include left ventricular ejection fraction and signal-averaged electrocardiograms, and for triggering events, the 24-hour continuous ECG recordings. Measures of heart rate variability defined as the variability of the instantaneous heart rates or heart period variability defined as variability of the normal R-R intervals may provide the means for non-invasive assessment of autonomic nervous system activity. In previous studies it has been shown that a broad band measure of heart period variability, the standard deviation of all normal R-R intervals in a continuous 24-hour ECG recording made eight to fourteen days after myocardial infarction, predicted mortality in the subsequent two to four years independently of left ventricular dysfunction and spontaneous ventricular arrhythmias. The six multicenter studies from which the data were drawn included: the Multicenter Post Infarction Program (MPIP), a longitudinal, observational study of 867 patients; the Multicenter Diltiazem Post Infarction Trial (MDPIT), a double-blind, randomized, placebo-controlled trial of 2,466 patients; the Cardiac Arrhythmia Pilot Study (CAPS), a double-blind, randomized, placebo-controlled trial of 502 patients; the Cardiac Arrhythmia Suppression Trial (CAST), a double-blind, randomized, placebo-controlled trial of 4,200 patients; Electrophysiologic Studies Versus Electrocardiographic Monitoring (ESVEM), a comparison of two methods for evaluating antiarrhythmic drug efficacy in 350 patients; and the Cardiac Rate/Rhythm in Normal Adults, a cross-sectional observational study of 250 subjects. DESIGN NARRATIVE: Measurements of short and long-term heart rate and heart period variability were compared. The day-to-day reproducibility and time course of change were determined in measures of heart rate variability and heart period variability in patients with myocardial infarction. The predictive accuracy of heart rate variability measured late after myocardial infarction for subsequent mortality and development of malignant ventricular arrhythmias was determined. Heart rate and heart period variability findings after myocardial infarction were compared with those in age and sex-matched normal subjects and with those made in patients with malignant ventricular arrhythmias.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

--Patients that have had myocardial infarction within 2 weeks - still in hospital and sedentary except for short walks in hospital corridors

Exclusion criteria

--Inadequate 24-hour ECG recordings

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026