Anxiety and Cardiovascular Autonomic Control
Primary Purpose
Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005471
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005471
Brief Title
Anxiety and Cardiovascular Autonomic Control
Study Type
Observational
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To evaluate the hypothesis that chronic anxiety and/or anxiety disorders resulted in hyperkinetic cardiovascular autonomic regulation, often associated with increased coronary risk.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sparrow
Organizational Affiliation
Brigham and Women's Hospital
12. IPD Sharing Statement
Citations:
PubMed Identifier
10721441
Citation
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. doi: 10.1007/BF02895966.
Results Reference
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PubMed Identifier
9989308
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. doi: 10.1007/BF02884448.
Results Reference
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PubMed Identifier
10913473
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. doi: 10.1016/s0002-9149(00)00850-x.
Results Reference
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Anxiety and Cardiovascular Autonomic Control
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