Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005235
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2000-05-25
Brief Title:
Heart Rate Variability and Sudden Cardiac Death
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
The Ability of Several Short-term Measures of RR Variability to Predict Mortality After Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2466 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 4200 patients Electrophysiologic Studies Versus Electrocardiographic Monitoring ESVEM a comparison of two methods for evaluating antiarrhythmic drug efficacy in 350 patients and the Cardiac RateRhythm 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
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 2466 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 4200 patients Electrophysiologic Studies Versus Electrocardiographic Monitoring ESVEM a comparison of two methods for evaluating antiarrhythmic drug efficacy in 350 patients and the Cardiac RateRhythm 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL041552 | NIH | None | httpsreporternihgovquickSearchR01HL041552 |