Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Death+12

+ Death, Sudden

+ Heart Arrest

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 1988
See protocol details

Summary

Principal SponsorColumbia University
Last updated: December 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1988

Actual date on which the first participant was enrolled.

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.

NCT00005235
Principal SponsorColumbia University
Last updated: December 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

715 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DeathDeath, SuddenHeart ArrestInfarctionIschemiaNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaCardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial InfarctionDeath, Sudden, Cardiac

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Columbia University

New York, United StatesOpen Columbia University in Google Maps
CompletedOne Study Center