Cardiovascular DiseasesNCT00005344
Mediators of Social Support in Coronary Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine prospectively the extent to which structural and functional aspects of social support influences 'hard' cardiac events such as death and non-fatal myocardial infarction in patients with coronary artery disease (CAD) and to identify the behavioral and biological mediators of these influences. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1992to Apr 1998
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine prospectively the extent to which structural and functional aspects of social support influences 'hard' cardiac events such as death and non-fatal myocardial infarction in patients with coronary artery disease (CAD) and to identify the behavioral and biological mediators of these influences.
Read the detailed description
BACKGROUND:
Besides extending our understanding of the mechanisms of social support effects on health, the findings of this project helped in the design and development of more effective and efficient approaches to secondary prevention in coronary artery disease.
DESIGN NARRATIVE:
Social support was assessed in a large consecutive cohort of coronary disease patients referred for diagnostic catheterization (Group A) and in a subgroup of medically treated patients (Group B) with severe coronary artery disease and/or poor left ventricular function with an expected two year 'hard' cardiac event rate (death or nonfatal myocardial infarction) of 25 percent or more. A brief baseline questionnaire assessment of structural and functional aspects of social support as well as other aspects of quality of life was obtained on all coronary artery disease patients without prior revascularization who were referred to the Duke University Cardiac Catheterization Laboratory over a three year period (Group A). Detailed questionnaire and interview assessment of perceived and received social support and psychological traits, that is hostility, was obtained on a high risk subgroup (Group B) and a randomly selected 10 percent subgroup of other Group A patients. Potential behavioral mediators (including smoking behavior, physical activity, medical care utilization) and biological mediators,(including vagal tone, ambulatory ischemic burden) of the social support effects on outcomes were measured in Group B patients and the random subset of Group A. Group A patients were followed by mailed questionnaire at three months and one year and then annually. Group B and the random subset of Group A returned for a one month clinic visit. At that time, repeat social support interviews were administered and patients were sent home with a 48 hour ambulatory ECG monitor to allow measurement of total ischemic burden and heart rate variability (vagal tone).
Group B patients and the random subset of Group A were then followed by telephone interview at one year and then annually. In addition, these patients had brief bimonthly telephone contacts to assess interval changes in social support as well as levels of environmental stress and mood states including depression and anger. All patients were followed for up to three years. Outcome events, including death and myocardial infarction, were ascertained at each point in follow-up. Multivariable analyses using the spline proportional hazards regression model tested the prognostic importance of the social support and psychological measures on outcome and evaluated the role of biological and behavioral variables as mediators, controlling for baseline disease severity.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Depression
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startMay 1992
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Daniel Mark, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005344
- Sponsor's protocol ID
- 4209
- Other IDs
- R01HL045702
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Burnett RE, Blumenthal JA, Mark DB, Leimberger JD, Califf RM. Distinguishing between early and late responders to symptoms of acute myocardial infarction. Am J Cardiol. 1995 May 15;75(15):1019-22. doi: 10.1016/s0002-9149(99)80716-4.
PubMed 7747681Von Dras DD, Siegler IC, Williams RB, Clapp-Channing N, Haney TL, Mark DB. Surrogate assessment of coronary artery disease patients' functional capacity. Soc Sci Med. 1997 May;44(10):1491-502. doi: 10.1016/s0277-9536(96)00269-9.
PubMed 9160439Hlatky MA, Lam LC, Lee KL, Clapp-Channing NE, Williams RB, Pryor DB, Califf RM, Mark DB. Job strain and the prevalence and outcome of coronary artery disease. Circulation. 1995 Aug 1;92(3):327-33. doi: 10.1161/01.cir.92.3.327.
PubMed 7634445Harlan WR 3rd, Sandler SA, Lee KL, Lam LC, Mark DB. Importance of baseline functional and socioeconomic factors for participation in cardiac rehabilitation. Am J Cardiol. 1995 Jul 1;76(1):36-9. doi: 10.1016/s0002-9149(99)80797-8.
PubMed 7793400Bosworth HB, Siegler IC, Brummett BH, Barefoot JC, Williams RB, Vitaliano PP, Clapp-Channing N, Lytle BL, Mark DB. The relationship between self-rated health and health status among coronary artery patients. J Aging Health. 1999 Nov;11(4):565-84. doi: 10.1177/089826439901100405.
PubMed 10848078Von Dras DD, Siegler IC, Barefoot JC, Williams RB, Mark DB. Coronary catherization patient and wife's perceptions of social support: effects due to characteristics of recipient, provider, and their interaction. Int J Aging Hum Dev. 2000;50(2):97-125. doi: 10.2190/CU9W-0XKW-R4AN-G1TD.
PubMed 10791611Bosworth HB, Siegler IC, Brummett BH, Barefoot JC, Williams RB, Clapp-Channing NE, Mark DB. The association between self-rated health and mortality in a well-characterized sample of coronary artery disease patients. Med Care. 1999 Dec;37(12):1226-36. doi: 10.1097/00005650-199912000-00006.
PubMed 10599604Brummett BH, Babyak MA, Barefoot JC, Bosworth HB, Clapp-Channing NE, Siegler IC, Williams RB Jr, Mark DB. Social support and hostility as predictors of depressive symptoms in cardiac patients one month after hospitalization: a prospective study. Psychosom Med. 1998 Nov-Dec;60(6):707-13. doi: 10.1097/00006842-199811000-00008.
PubMed 9847029Bolotnikova FI, Polushina TV, Kuznetsova VM, Sirotkina VP. [Use of a freeze-drief culture of Leuconostoc mesenteroides for the synthesis of dextran]. Prikl Biokhim Mikrobiol. 1975 Jan-Feb;11(1):141-4. Russian.
PubMed 1129227
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediators of Social Support in Coronary Disease
- ClinicalTrials.gov ID
- NCT00005344
- Acronym / sponsor ID
- 4209
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1992
- Study completion
- Apr 1998 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine prospectively the extent to which structural and functional aspects of social support influences 'hard' cardiac events such as death and non-fatal myocardial infarction in patients with coronary artery disease (CAD) and to identify the behavioral and biological mediators of these influences.
Detailed description
BACKGROUND:
Besides extending our understanding of the mechanisms of social support effects on health, the findings of this project helped in the design and development of more effective and efficient approaches to secondary prevention in coronary artery disease.
DESIGN NARRATIVE:
Social support was assessed in a large consecutive cohort of coronary disease patients referred for diagnostic catheterization (Group A) and in a subgroup of medically treated patients (Group B) with severe coronary artery disease and/or poor left ventricular function with an expected two year 'hard' cardiac event rate (death or nonfatal myocardial infarction) of 25 percent or more. A brief baseline questionnaire assessment of structural and functional aspects of social support as well as other aspects of quality of life was obtained on all coronary artery disease patients without prior revascularization who were referred to the Duke University Cardiac Catheterization Laboratory over a three year period (Group A). Detailed questionnaire and interview assessment of perceived and received social support and psychological traits, that is hostility, was obtained on a high risk subgroup (Group B) and a randomly selected 10 percent subgroup of other Group A patients. Potential behavioral mediators (including smoking behavior, physical activity, medical care utilization) and biological mediators,(including vagal tone, ambulatory ischemic burden) of the social support effects on outcomes were measured in Group B patients and the random subset of Group A. Group A patients were followed by mailed questionnaire at three months and one year and then annually. Group B and the random subset of Group A returned for a one month clinic visit. At that time, repeat social support interviews were administered and patients were sent home with a 48 hour ambulatory ECG monitor to allow measurement of total ischemic burden and heart rate variability (vagal tone).
Group B patients and the random subset of Group A were then followed by telephone interview at one year and then annually. In addition, these patients had brief bimonthly telephone contacts to assess interval changes in social support as well as levels of environmental stress and mood states including depression and anger. All patients were followed for up to three years. Outcome events, including death and myocardial infarction, were ascertained at each point in follow-up. Multivariable analyses using the spline proportional hazards regression model tested the prognostic importance of the social support and psychological measures on outcome and evaluated the role of biological and behavioral variables as mediators, controlling for baseline disease severity.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 7747681Burnett RE, Blumenthal JA, Mark DB, Leimberger JD, Califf RM. Distinguishing between early and late responders to symptoms of acute myocardial infarction. Am J Cardiol. 1995 May 15;75(15):1019-22. doi: 10.1016/s0002-9149(99)80716-4.
- Background: PubMed 9160439Von Dras DD, Siegler IC, Williams RB, Clapp-Channing N, Haney TL, Mark DB. Surrogate assessment of coronary artery disease patients' functional capacity. Soc Sci Med. 1997 May;44(10):1491-502. doi: 10.1016/s0277-9536(96)00269-9.
- Background: PubMed 7634445Hlatky MA, Lam LC, Lee KL, Clapp-Channing NE, Williams RB, Pryor DB, Califf RM, Mark DB. Job strain and the prevalence and outcome of coronary artery disease. Circulation. 1995 Aug 1;92(3):327-33. doi: 10.1161/01.cir.92.3.327.
- Background: PubMed 7793400Harlan WR 3rd, Sandler SA, Lee KL, Lam LC, Mark DB. Importance of baseline functional and socioeconomic factors for participation in cardiac rehabilitation. Am J Cardiol. 1995 Jul 1;76(1):36-9. doi: 10.1016/s0002-9149(99)80797-8.
- Background: PubMed 10848078Bosworth HB, Siegler IC, Brummett BH, Barefoot JC, Williams RB, Vitaliano PP, Clapp-Channing N, Lytle BL, Mark DB. The relationship between self-rated health and health status among coronary artery patients. J Aging Health. 1999 Nov;11(4):565-84. doi: 10.1177/089826439901100405.
- Background: PubMed 10791611Von Dras DD, Siegler IC, Barefoot JC, Williams RB, Mark DB. Coronary catherization patient and wife's perceptions of social support: effects due to characteristics of recipient, provider, and their interaction. Int J Aging Hum Dev. 2000;50(2):97-125. doi: 10.2190/CU9W-0XKW-R4AN-G1TD.
- Background: PubMed 10599604Bosworth HB, Siegler IC, Brummett BH, Barefoot JC, Williams RB, Clapp-Channing NE, Mark DB. The association between self-rated health and mortality in a well-characterized sample of coronary artery disease patients. Med Care. 1999 Dec;37(12):1226-36. doi: 10.1097/00005650-199912000-00006.
- Background: PubMed 9847029Brummett BH, Babyak MA, Barefoot JC, Bosworth HB, Clapp-Channing NE, Siegler IC, Williams RB Jr, Mark DB. Social support and hostility as predictors of depressive symptoms in cardiac patients one month after hospitalization: a prospective study. Psychosom Med. 1998 Nov-Dec;60(6):707-13. doi: 10.1097/00006842-199811000-00008.
- Background: PubMed 1129227Bolotnikova FI, Polushina TV, Kuznetsova VM, Sirotkina VP. [Use of a freeze-drief culture of Leuconostoc mesenteroides for the synthesis of dextran]. Prikl Biokhim Mikrobiol. 1975 Jan-Feb;11(1):141-4. Russian.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Mark
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005344, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.