Social Support and Myocardial Ischemia
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia
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
NCT00005449
First Posted
May 25, 2000
Last Updated
January 7, 2016
Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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