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Social Support and Myocardial Ischemia

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Florida
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
    January 7, 2016
    Sponsor
    University of Florida
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005449
    Brief Title
    Social Support and Myocardial Ischemia
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2001 (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To examine the role of social support in attenuating ischemic responses to psychological stress, both in the laboratory and during daily life.
    Detailed Description
    BACKGROUND: A large quantity of epidemiological data has accumulated attesting to a link between social support and the progression of cardiovascular disease in cardiac patients. One way that social support might exerts its health effects is by attenuating physiological responses to psychological stress, since these responses have been related to cardiovascular disease. Much myocardial ischemia occurring during daily life appears to be related to periods of psychological stress, and laboratory mental stress tasks have been found to induce ischemia. Thus, the incidence, severity, and duration of myocardial ischemia might be modified by changes in the social environment. DESIGN NARRATIVE: There are two components to the study. In the first component, the investigators are testing the hypothesis that the presence of a supportive spouse attenuates ischemic responses to psychological stress in the laboratory. Using a counterbalanced crossover, repeated measures design, patients are asked to complete a public speaking task in the laboratory in two conditions: with a spouse present; and alone. Hemodynamic, radionuclide angiographic, and catecholamine responses to the task are assessed in both conditions. In the second component, the investigators are examining whether married patients show reduced duration of ischemia compared to unmarried patients. In addition, they plan to examine whether presence of a supportive other (spouse, or friend in the case of unmarried patients) reduces the incidence and duration of ischemia in patients during daily life activities. Patients are asked to keep a detailed diary for a two week period to ascertain patterns of daily activities. Using these diaries and in consultation with patients, the investigators are selecting a two day period during which patients have a busy and varied schedule. Patients are then asked to follow the same pattern of activities for a 48 hour period on two consecutive weeks when heart rate, and the incidence and duration of ischemia are measured. During one week their spouse, in the case of married patients, or friend, in the case of unmarried patients, is present; during the other week patients are to repeat the activities alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Coronary Disease

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10234428
    Citation
    Carroll D, Sheffield D. Social psychophysiology, social circumstances, and health. Ann Behav Med. 1998 Fall;20(4):333-7. doi: 10.1007/BF02886383.
    Results Reference
    background
    PubMed Identifier
    10073794
    Citation
    Sheffield D, Kirby DS, Biles PL, Sheps DS. Comparison of perception of angina pectoris during exercise testing in African-Americans versus Caucasians. Am J Cardiol. 1999 Jan 1;83(1):106-8, A8. doi: 10.1016/s0002-9149(98)00790-5.
    Results Reference
    background

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    Social Support and Myocardial Ischemia

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