AzTrials
AzTrials

Cardiovascular DiseasesNCT00005235

Heart Rate Variability and Sudden Cardiac Death

An observational study of Cardiovascular Diseases and Coronary Disease, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
How many people
715 participants
Where
1 siteUnited States
Study dates
Dec 1988to Sep 1993
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants in the Multicenter Post Infarction Program (MPIP), a natural history study

Who may be able to join

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

Who cannot join

  • --Inadequate 24-hour ECG recordings

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

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

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

Read the 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.

Medical subject headings
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Death, Sudden, Cardiac

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startDec 1988
  3. Primary completionSep 1993
  4. Study completionSep 1993

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
715 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005235
Sponsor's protocol ID
CUMC ID unknown (1116)
Other IDs
R01HL041552
Status last verified
Dec 2015
First submitted
25 May 2000
Last updated
24 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bigger JT Jr, Albrecht P, Steinman RC, Rolnitzky LM, Fleiss JL, Cohen RJ. Comparison of time- and frequency domain-based measures of cardiac parasympathetic activity in Holter recordings after myocardial infarction. Am J Cardiol. 1989 Sep 1;64(8):536-8. doi: 10.1016/0002-9149(89)90436-0. No abstract available.

    PubMed 2773799

  • Bigger JT Jr, La Rovere MT, Steinman RC, Fleiss JL, Rottman JN, Rolnitzky LM, Schwartz PJ. Comparison of baroreflex sensitivity and heart period variability after myocardial infarction. J Am Coll Cardiol. 1989 Nov 15;14(6):1511-8. doi: 10.1016/0735-1097(89)90390-2.

    PubMed 2809012

  • Rottman JN, Steinman RC, Albrecht P, Bigger JT Jr, Rolnitzky LM, Fleiss JL. Efficient estimation of the heart period power spectrum suitable for physiologic or pharmacologic studies. Am J Cardiol. 1990 Dec 15;66(20):1522-4. doi: 10.1016/0002-9149(90)90551-b. No abstract available.

    PubMed 2252008

  • Bigger JT Jr, Fleiss JL. The variability of spontaneous ventricular arrhythmias in the year after myocardial infarction. J Am Coll Cardiol. 1991 Jan;17(1):9-10. doi: 10.1016/0735-1097(91)90698-9. No abstract available.

    PubMed 1702796

  • Goldsmith RL, Bigger JT Jr, Steinman RC, Fleiss JL. Comparison of 24-hour parasympathetic activity in endurance-trained and untrained young men. J Am Coll Cardiol. 1992 Sep;20(3):552-8. doi: 10.1016/0735-1097(92)90007-a.

    PubMed 1512332

  • Fleiss JL, Bigger JT Jr, Rolnitzky LM. The correlation between heart period variability and mean period length. Stat Med. 1992 Jan 15;11(1):125-9. doi: 10.1002/sim.4780110111.

    PubMed 1557568

  • Bigger JT Jr, Fleiss JL, Steinman RC, Rolnitzky LM, Kleiger RE, Rottman JN. Correlations among time and frequency domain measures of heart period variability two weeks after acute myocardial infarction. Am J Cardiol. 1992 Apr 1;69(9):891-8. doi: 10.1016/0002-9149(92)90788-z.

    PubMed 1550018

  • Bigger JT Jr, Fleiss JL, Rolnitzky LM, Steinman RC. Stability over time of heart period variability in patients with previous myocardial infarction and ventricular arrhythmias. The CAPS and ESVEM investigators. Am J Cardiol. 1992 Mar 15;69(8):718-23. doi: 10.1016/0002-9149(92)90493-i.

    PubMed 1546643

  • Bigger JT Jr, Fleiss JL, Steinman RC, Rolnitzky LM, Kleiger RE, Rottman JN. Frequency domain measures of heart period variability and mortality after myocardial infarction. Circulation. 1992 Jan;85(1):164-71. doi: 10.1161/01.cir.85.1.164.

    PubMed 1728446

  • Bigger JT Jr, Fleiss JL, Rolnitzky LM, Steinman RC, Schneider WJ. Time course of recovery of heart period variability after myocardial infarction. J Am Coll Cardiol. 1991 Dec;18(7):1643-9. doi: 10.1016/0735-1097(91)90497-w.

    PubMed 1960309

  • Kleiger RE, Bigger JT, Bosner MS, Chung MK, Cook JR, Rolnitzky LM, Steinman R, Fleiss JL. Stability over time of variables measuring heart rate variability in normal subjects. Am J Cardiol. 1991 Sep 1;68(6):626-30. doi: 10.1016/0002-9149(91)90355-o.

    PubMed 1877480

  • Cook JR, Bigger JT Jr, Kleiger RE, Fleiss JL, Steinman RC, Rolnitzky LM. Effect of atenolol and diltiazem on heart period variability in normal persons. J Am Coll Cardiol. 1991 Feb;17(2):480-4. doi: 10.1016/s0735-1097(10)80119-6.

    PubMed 1991906

  • Bigger JT Jr, Rolnitzky LM, Steinman RC, Fleiss JL. Predicting mortality after myocardial infarction from the response of RR variability to antiarrhythmic drug therapy. J Am Coll Cardiol. 1994 Mar 1;23(3):733-40. doi: 10.1016/0735-1097(94)90761-7.

    PubMed 7509355

  • Bloomfield DM, Bigger JT Jr, Pavri BB, Han J, Fleiss JL, Rolnitzky LM, Steinman RC. Vagal modulation of RR intervals during head-up tilt and the infusion of isoproterenol. Am J Cardiol. 1995 Jun 1;75(16):1145-50. doi: 10.1016/s0002-9149(99)80747-4.

    PubMed 7762502

  • Bigger JT Jr, Fleiss JL, Steinman RC, Rolnitzky LM, Schneider WJ, Stein PK. RR variability in healthy, middle-aged persons compared with patients with chronic coronary heart disease or recent acute myocardial infarction. Circulation. 1995 Apr 1;91(7):1936-43. doi: 10.1161/01.cir.91.7.1936.

    PubMed 7895350

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Coronary Disease, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005235, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.

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