Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005449
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2000-05-25
Brief Title:
Social Support and Myocardial Ischemia
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL056825 | NIH | None | httpsreporternihgovquickSearchR29HL056825 |