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Heart Rate Variability and Sudden Cardiac Death

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00005235
First received: May 25, 2000
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
To evaluate the ability of heart rate variability to identify myocardial infarction patients at high risk of dying, particularly from sudden cardiac death.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Ability of Several Short-term Measures of RR Variability to Predict Mortality After Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Columbia University:

Enrollment: 715
Study Start Date: December 1988
Study Completion Date: September 1993
Primary Completion Date: September 1993 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants in the Multicenter Post Infarction Program (MPIP), a natural history study
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005235

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: John Bigger, MD Professor Emeritus of Medicine and Pharmacology, Columbia University
  More Information

Publications:

Study Data/Documents: NCBI website  This link exits the ClinicalTrials.gov site

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00005235     History of Changes
Other Study ID Numbers: CUMC ID unknown (1116)  R01HL041552 
Study First Received: May 25, 2000
Last Updated: December 22, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Death
Coronary Disease
Coronary Artery Disease
Death, Sudden
Death, Sudden, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Heart Arrest

ClinicalTrials.gov processed this record on December 09, 2016