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Anxiety and Cardiovascular Autonomic Control

Primary Purpose

Cardiovascular Diseases, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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
    background
    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
    background
    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
    background

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    Anxiety and Cardiovascular Autonomic Control

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