NCT00005235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
715

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 1988

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1988

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1993

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1993

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

4.8 years

First QC Date

May 25, 2000

Last Update Submit

December 22, 2015

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial InfarctionDeath, Sudden, CardiacVentricular Arrhythmia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Inadequate 24-hour ECG recordings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (18)

  • 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.

    PMID: 2773799BACKGROUND

  • 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.

    PMID: 2809012BACKGROUND

  • 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.

    PMID: 2252008BACKGROUND

  • 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.

    PMID: 1702796BACKGROUND

  • 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.

    PMID: 1512332BACKGROUND

  • 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.

    PMID: 1557568BACKGROUND

  • 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.

    PMID: 1550018BACKGROUND

  • 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.

    PMID: 1546643BACKGROUND

  • 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.

    PMID: 1728446BACKGROUND

  • 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.

    PMID: 1960309BACKGROUND

  • 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.

    PMID: 1877480BACKGROUND

  • 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.

    PMID: 1991906BACKGROUND

  • 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.

    PMID: 7509355BACKGROUND

  • 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.

    PMID: 7762502BACKGROUND

  • 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.

    PMID: 7895350BACKGROUND

  • Bigger JT, Fleiss JL, Rolnitzky LM, Steinman RC. The ability of several short-term measures of RR variability to predict mortality after myocardial infarction. Circulation. 1993 Sep;88(3):927-34. doi: 10.1161/01.cir.88.3.927.

    PMID: 8353919BACKGROUND

  • Kaufman ES, Bosner MS, Bigger JT Jr, Stein PK, Kleiger RE, Rolnitzky LM, Steinman RC, Fleiss JL. Effects of digoxin and enalapril on heart period variability and response to head-up tilt in normal subjects. Am J Cardiol. 1993 Jul 1;72(1):95-9. doi: 10.1016/0002-9149(93)90226-3.

    PMID: 8517437BACKGROUND

  • Bigger JT Jr, Fleiss JL, Rolnitzky LM, Steinman RC. Frequency domain measures of heart period variability to assess risk late after myocardial infarction. J Am Coll Cardiol. 1993 Mar 1;21(3):729-36. doi: 10.1016/0735-1097(93)90106-b.

    PMID: 8436755BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial InfarctionDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHeart ArrestDeath, SuddenDeath

Study Officials

  • John Bigger, MD

    Professor Emeritus of Medicine and Pharmacology, Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

December 1, 1988

Primary Completion

September 1, 1993

Study Completion

September 1, 1993

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(1)