Social Support and Myocardial Ischemia

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005449
• Other study ID #: 4378
• Secondary ID: R29HL056825
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: January 7, 2016
• Start date: August 1996
• Est. completion date: June 2001

Study information

• Verified date: January 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To examine the role of social support in attenuating ischemic responses to psychological stress, both in the laboratory and during daily life.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

Carroll D, Sheffield D. Social psychophysiology, social circumstances, and health. Ann Behav Med. 1998 Fall;20(4):333-7. Review. — View 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. — View Citation