Cardiovascular DiseasesNCT00005334
Effects of Personality and Context on Recovery From Coronary Artery Bypass
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To study the personality and environmental factors that may determine the short-term and long-term sequelae of coronary artery bypass surgery (CABS). 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
- Jul 1991to Jun 1995
- 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 study the personality and environmental factors that may determine the short-term and long-term sequelae of coronary artery bypass surgery (CABS).
Read the detailed description
BACKGROUND:
Coronary artery bypass surgery, or CABS, is one of the most common surgical procedures for treating patients with coronary artery disease (CAD). A significant number of patients have accelerated atherosclerosis in the postsurgical period and require second and third operations. Moreover, relative to standard medical care, CABS does little to prolong life. The major benefit of the procedure is improving life quality. Thus, to enhance this major benefit of CABS, it is important to understand the factors, psychosocial as well as biological, that might enhance quality of life after CABS. The few available studies on the psychosocial aspects of recovery from CABS suggest that person variables evident prior to surgery are related to postsurgery quality of life. Of special interest here are gender, optimism, Type A, with its component behavior of hostility, and repressive style. The significance of these attributes derives from their theoretical and empirical relationships to the patient's illness representations and correspondent coping responses, and/or their relationship to risk for coronary heart disease (CHD). In addition to person variables, a number of environmental variables might also be expected to play a role in recovery. Variables such as socioeconomic status (SES), major life events, and quantity and quality of social support systems have all been shown to impact on health and illness. Moreover, from a slightly different perspective, the patient's illness itself can serve as an environmental variable impinging on the life of the person providing the primary support. Thus, it is also important to understand how the patient's illness impacts on the provider of the primary support.
DESIGN NARRATIVE:
A total of 305 patients between the ages of 25 and 70 scheduled for elective surgery at a major local hospital were evaluated two weeks prior to surgery on the day prior to surgery, and one week, six months, and two and a half years postsurgery. Primary support persons were evaluated three times--at intake, six months postsurgery, and two and a half years postsurgery. Medical information was obtained that permitted examination of the influences of psychosocial variables on recovery. Major personality variables under investigation were optimism, Type A, hostility, gender, repressive style, and to a lesser extent, anxiety, and neuroticism. Major environmental variables included quality and quantity of social support and availability of a primary support person. Main outcome variables for patients included satisfaction with different life domains, depression, return to work, normalization of life style, and new and recurrent morbidity. Main outcome variables for the support person included perceptions of burden, depression, and life satisfaction.
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, Depression
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, 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 startJul 1991
- Study completionJun 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005334
- Sponsor's protocol ID
- 4189
- Other IDs
- R01HL044436
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.
PubMed 7815302Carver CS, Scheier MF. Situational coping and coping dispositions in a stressful transaction. J Pers Soc Psychol. 1994 Jan;66(1):184-95. doi: 10.1037//0022-3514.66.1.184.
PubMed 8126648Carver CS, Pozo C, Harris SD, Noriega V, Scheier MF, Robinson DS, Ketcham AS, Moffat FL Jr, Clark KC. How coping mediates the effect of optimism on distress: a study of women with early stage breast cancer. J Pers Soc Psychol. 1993 Aug;65(2):375-90. doi: 10.1037//0022-3514.65.2.375.
PubMed 8366426Newsom JT, Schulz R. Social support as a mediator in the relation between functional status and quality of life in older adults. Psychol Aging. 1996 Mar;11(1):34-44. doi: 10.1037/0882-7974.11.1.34.
PubMed 8726368Scheier MF, Bridges MW. Person variables and health: personality predispositions and acute psychological states as shared determinants for disease. Psychosom Med. 1995 May-Jun;57(3):255-68. doi: 10.1097/00006842-199505000-00007.
PubMed 7652126Scheier MF, Matthews KA, Owens JF, Schulz R, Bridges MW, Magovern GJ, Carver CS. Optimism and rehospitalization after coronary artery bypass graft surgery. Arch Intern Med. 1999 Apr 26;159(8):829-35. doi: 10.1001/archinte.159.8.829.
PubMed 10219928Nieboer AP, Schulz R, Matthews KA, Scheier MF, Ormel J, Lindenberg SM. Spousal caregivers' activity restriction and depression: a model for changes over time. Soc Sci Med. 1998 Nov;47(9):1361-71. doi: 10.1016/s0277-9536(98)00214-7.
PubMed 9783879
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personality and Context on Recovery From Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT00005334
- Acronym / sponsor ID
- 4189
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1991
- Study completion
- Jun 1995 (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 study the personality and environmental factors that may determine the short-term and long-term sequelae of coronary artery bypass surgery (CABS).
Detailed description
BACKGROUND:
Coronary artery bypass surgery, or CABS, is one of the most common surgical procedures for treating patients with coronary artery disease (CAD). A significant number of patients have accelerated atherosclerosis in the postsurgical period and require second and third operations. Moreover, relative to standard medical care, CABS does little to prolong life. The major benefit of the procedure is improving life quality. Thus, to enhance this major benefit of CABS, it is important to understand the factors, psychosocial as well as biological, that might enhance quality of life after CABS. The few available studies on the psychosocial aspects of recovery from CABS suggest that person variables evident prior to surgery are related to postsurgery quality of life. Of special interest here are gender, optimism, Type A, with its component behavior of hostility, and repressive style. The significance of these attributes derives from their theoretical and empirical relationships to the patient's illness representations and correspondent coping responses, and/or their relationship to risk for coronary heart disease (CHD). In addition to person variables, a number of environmental variables might also be expected to play a role in recovery. Variables such as socioeconomic status (SES), major life events, and quantity and quality of social support systems have all been shown to impact on health and illness. Moreover, from a slightly different perspective, the patient's illness itself can serve as an environmental variable impinging on the life of the person providing the primary support. Thus, it is also important to understand how the patient's illness impacts on the provider of the primary support.
DESIGN NARRATIVE:
A total of 305 patients between the ages of 25 and 70 scheduled for elective surgery at a major local hospital were evaluated two weeks prior to surgery on the day prior to surgery, and one week, six months, and two and a half years postsurgery. Primary support persons were evaluated three times--at intake, six months postsurgery, and two and a half years postsurgery. Medical information was obtained that permitted examination of the influences of psychosocial variables on recovery. Major personality variables under investigation were optimism, Type A, hostility, gender, repressive style, and to a lesser extent, anxiety, and neuroticism. Major environmental variables included quality and quantity of social support and availability of a primary support person. Main outcome variables for patients included satisfaction with different life domains, depression, return to work, normalization of life style, and new and recurrent morbidity. Main outcome variables for the support person included perceptions of burden, depression, and life satisfaction.
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 16 Mar 2016.
- Background: PubMed 7815302Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.
- Background: PubMed 8126648Carver CS, Scheier MF. Situational coping and coping dispositions in a stressful transaction. J Pers Soc Psychol. 1994 Jan;66(1):184-95. doi: 10.1037//0022-3514.66.1.184.
- Background: PubMed 8366426Carver CS, Pozo C, Harris SD, Noriega V, Scheier MF, Robinson DS, Ketcham AS, Moffat FL Jr, Clark KC. How coping mediates the effect of optimism on distress: a study of women with early stage breast cancer. J Pers Soc Psychol. 1993 Aug;65(2):375-90. doi: 10.1037//0022-3514.65.2.375.
- Background: PubMed 8726368Newsom JT, Schulz R. Social support as a mediator in the relation between functional status and quality of life in older adults. Psychol Aging. 1996 Mar;11(1):34-44. doi: 10.1037/0882-7974.11.1.34.
- Background: PubMed 7652126Scheier MF, Bridges MW. Person variables and health: personality predispositions and acute psychological states as shared determinants for disease. Psychosom Med. 1995 May-Jun;57(3):255-68. doi: 10.1097/00006842-199505000-00007.
- Background: PubMed 10219928Scheier MF, Matthews KA, Owens JF, Schulz R, Bridges MW, Magovern GJ, Carver CS. Optimism and rehospitalization after coronary artery bypass graft surgery. Arch Intern Med. 1999 Apr 26;159(8):829-35. doi: 10.1001/archinte.159.8.829.
- Background: PubMed 9783879Nieboer AP, Schulz R, Matthews KA, Scheier MF, Ormel J, Lindenberg SM. Spousal caregivers' activity restriction and depression: a model for changes over time. Soc Sci Med. 1998 Nov;47(9):1361-71. doi: 10.1016/s0277-9536(98)00214-7.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 16 Mar 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 NCT00005334, which also lists 7 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 16 Mar 2016.