NCT00005399

Brief Summary

To examine factors affecting heart rate variability (HRV) and the role of HRV in heart disease. Specifically, to examine the role of HRV: as a predictor of fatal and nonfatal ischemic heart disease over a six year follow-up of the Atherosclerosis Risk in Communities (ARIC) population based, bi-ethnic cohort; on the six year progression of carotid atherosclerosis measured by B-mode ultrasound; and on the incidence of hypertension. Also, to study the effect of elevated fasting insulin, glucose, diabetes mellitus, and other metabolic abnormalities on changes in HRV over nine years of follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
111,654

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1996

Longer than P75 for all trials

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

August 1, 1996

Completed
3.8 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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

4.8 years

First QC Date

May 25, 2000

Last Update Submit

April 11, 2016

Conditions

Cardiovascular DiseasesMyocardial IschemiaCarotid StenosisHypertensionDiabetes MellitusHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Incident coronary heart disease and stroke events

    10-year follow-up

Secondary Outcomes (1)

  • all-cause and cause-specific mortality

    10-year follow-up

Interventions

No interventionsOTHER

No interventions

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Population-based sample of adults ages 45-64 years

Residents of 4 geographically defined areas

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Liao D, Sloan RP, Cascio WE, Folsom AR, Liese AD, Evans GW, Cai J, Sharrett AR. Multiple metabolic syndrome is associated with lower heart rate variability. The Atherosclerosis Risk in Communities Study. Diabetes Care. 1998 Dec;21(12):2116-22. doi: 10.2337/diacare.21.12.2116.

    PMID: 9839103BACKGROUND

  • Carnethon MR, Liao D, Evans GW, Cascio WE, Chambless LE, Rosamond WD, Heiss G. Does the cardiac autonomic response to postural change predict incident coronary heart disease and mortality? The Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2002 Jan 1;155(1):48-56. doi: 10.1093/aje/155.1.48.

    PMID: 11772784BACKGROUND

  • Carnethon MR, Liao D, Evans GW, Cascio WE, Chambless LE, Heiss G. Correlates of the shift in heart rate variability with an active postural change in a healthy population sample: The Atherosclerosis Risk In Communities study. Am Heart J. 2002 May;143(5):808-13. doi: 10.1067/mhj.2002.121928.

    PMID: 12040341BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial IschemiaCarotid StenosisHypertensionDiabetes MellitusHeart Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gerardo Heiss

    University of North Carolina

    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

August 1, 1996

Primary Completion

June 1, 2001

Study Completion

June 1, 2001

Last Updated

April 12, 2016

Record last verified: 2016-04