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Hostility and Coronary Risk--Role of Weak Vagal Function

Primary Purpose

Cardiovascular Diseases, Coronary Disease, 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
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005337
    Brief Title
    Hostility and Coronary Risk--Role of Weak Vagal Function
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1995 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine whether deficient vagal antagonism of sympathetic nervous system (SNS) actions on the heart contributed to increased coronary heart disease risk in hostile persons.
    Detailed Description
    DESIGN NARRATIVE: Sophisticated electrophysiologic monitoring approaches were used to: 1) show greater sensitivity in nonhostile young men to T-wave attenuation effects of isoproterenol infusion following vagal blockade; 2) show that vagal enhancement reduced and shortened the T-wave attenuation effects of isoproterenol infusion more in hostile young men; 3) evaluate these effects of vagal blockage and enhancement in middle-aged men and in young and middle-aged women; and 4) relate the T-wave effects in these studies to other measures of vagal tone and other biobehavioral mechanisms of coronary-prone behavior. Four studies were conducted in normal young and middle-aged men and women selected as high and low on hostility, evaluating vagal tone measures and effects of isoproterenol infusion on EKG T-wave and ST response after pretreatment with saline, neostigmine, and atropine. Demonstration that hostility was associated with deficient vagal anatagonism of SNS effects on the heart, especially in middle-aged as compared to younger persons, suggested that diminished vagal tone was one pathway whereby high hostility contributed to increased CHD risk. Clinical studies were then conducted to determine whether weaker vagal tone predicted increased myocardial ischemia and/or poorer outcomes in coronary heart disease patients. 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, Coronary Disease, Heart Diseases, Myocardial Ischemia

    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
    Redford Williams
    Organizational Affiliation
    Duke University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9624030
    Citation
    Williams RB. Lower socioeconomic status and increased mortality: early childhood roots and the potential for successful interventions. JAMA. 1998 Jun 3;279(21):1745-6. doi: 10.1001/jama.279.21.1745. No abstract available.
    Results Reference
    background
    PubMed Identifier
    9610159
    Citation
    Williams RB. The mind, the body, health, and disease. What do we know, what should we do? N C Med J. 1998 May-Jun;59(3):172-4. No abstract available.
    Results Reference
    background
    PubMed Identifier
    8831391
    Citation
    Barefoot JC, Helms MJ, Mark DB, Blumenthal JA, Califf RM, Haney TL, O'Connor CM, Siegler IC, Williams RB. Depression and long-term mortality risk in patients with coronary artery disease. Am J Cardiol. 1996 Sep 15;78(6):613-7. doi: 10.1016/s0002-9149(96)00380-3.
    Results Reference
    background
    PubMed Identifier
    1317272
    Citation
    Fukudo S, Lane JD, Anderson NB, Kuhn CM, Schanberg SM, McCown N, Muranaka M, Suzuki J, Williams RB Jr. Accentuated vagal antagonism of beta-adrenergic effects on ventricular repolarization. Evidence of weaker antagonism in hostile type A men. Circulation. 1992 Jun;85(6):2045-53. doi: 10.1161/01.cir.85.6.2045.
    Results Reference
    background
    PubMed Identifier
    11270067
    Citation
    Williams RB. Hostility and heart disease: Williams et al. (1980). Adv Mind Body Med. 2001 Winter;17(1):52-5. No abstract available.
    Results Reference
    background

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