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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005471
Other study ID # 4953
Secondary ID R01HL054098
Status Completed
Phase N/A
First received May 25, 2000
Last updated March 15, 2016
Start date September 1996
Est. completion date January 2001

Study information

Verified date March 2005
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To evaluate the hypothesis that chronic anxiety and/or anxiety disorders resulted in hyperkinetic cardiovascular autonomic regulation, often associated with increased coronary risk.


Description:

BACKGROUND:

Prospective epidemiologic data indicate a strong relationship of chronic anxiety and/or anxiety disorders to risk of sudden cardiac death. Other studies have shown that cardiac autonomic mechanisms are altered among stably anxious individuals in the direction of reduced parasympathetic and elevated sympathetic control. The latter investigations, however, have been based on very small clinic samples and have been incomplete in their assessment of cardiovascular regulation in anxiety.

This investigation was the first large-scale population-based research examining the cardiovascular physiology of anxiety, and helped to increase understanding of the reported association between anxiety and sudden cardiac death. This study also helped to identify groups in the general population at increased risk of sudden death.

DESIGN NARRATIVE:

The study used an ongoing well-characterized cohort, the VA Normative Aging Study (NAS), to recruit middle-aged and older community-dwelling men and women into the study. Using a variety of validated psychological and psychiatric screening instruments--including the Brief Symptom Inventory, the Composite International Diagnostic Interview, the Spielberger State-Trait Anxiety Inventory, and the Crown-Crisp Index--the study population was characterized in terms of symptoms of anxiety and diagnosis of anxiety disorders. Cardiovascular autonomic control was then assessed among anxious and non-anxious individuals using non-invasive time-domain and power-spectral measures of heart rate and blood pressure variability. Cardiac output, total peripheral resistance, and end-tidal pCO2 were simultaneously assessed.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

Kubzansky LD, Kawachi I, Sparrow D. Socioeconomic status, hostility, and risk factor clustering in the Normative Aging Study: any help from the concept of allostatic load? Ann Behav Med. 1999 Fall;21(4):330-8. — View Citation

Kubzansky LD, Kawachi I, Weiss ST, Sparrow D. Anxiety and coronary heart disease: a synthesis of epidemiological, psychological, and experimental evidence. Ann Behav Med. 1998 Spring;20(2):47-58. Review. — View Citation

Siegman AW, Kubzansky LD, Kawachi I, Boyle S, Vokonas PS, Sparrow D. A prospective study of dominance and coronary heart disease in the Normative Aging Study. Am J Cardiol. 2000 Jul 15;86(2):145-9. — View Citation

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