Biobehavioral Predictors of Coronary Angioplasty Outcome
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | February 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00005554 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biobehavioral Predictors of Coronary Angioplasty Outcome | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | To examine some of the psychosocial predictors of poor outcome among revascularized coronary artery disease patients. |
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| Detailed Description | BACKGROUND: Percutaneous coronary revascularization procedures are increasingly used in the treatment of coronary artery disease, with approximately 300,000 interventions performed each year. Despite new developments in cardiology such as intra-coronary stents and anticoagulant pharmacological treatments, a major problem remains the frequent occurrence of coronary restenosis and new cardiac events within six months after the intervention. These adverse outcomes occur in one out of four patients and have substantial impact on the costs of medical care and patients' quality of life. Research indicated that hemostatic factors (e.g., fibrinogen, von Willebrand factor, and plasminogen activator inhibitor) promote the formation of blood clots and that these factors predict coronary restenosis. Moreover, prior longitudinal studies have also demonstrated that the psychosocial traits of hostility and depression affect clinical progression of coronary disease. These psychosocial factors significantly predict adverse long-term outcome after revascularization and both hostility and depression are known to affect blood clotting factors. In addition, acute mental and physical stress are reported to affect blood clotting factors (coagulation and fibrinolysis) and responses to stress are reported to be more pronounced in hostile individuals. However, previous research on predictors of adverse clinical outcome after percutaneous coronary revascularization has not examined stress-induced changes in hemostatic factors and the consequences of these responses for progression of coronary artery disease. Therefore, the study investigates whether psychosocial factors and responses to acute mental stress affect measures of the blood clotting process that are involved in progression of coronary disease, thereby increasing the risk of an adverse prognosis following percutaneous coronary revascularization. This study may improve the identification of patients at risk for recurrent cardiac events and provide further understanding of the pathophysiological mechanisms involved in the progression of coronary artery disease. DESIGN NARRATIVE: The study investigated whether psychosocial factors and responses to acute mental stress affected measures of the blood clotting process that are involved in progression of coronary disease, thereby increasing the risk of an adverse prognosis following percutaneous coronary revascularization. This study helped to improve the identification of patients at risk for recurrent cardiac events and provided further understanding of the pathophysiological mechanisms involved in the progression of coronary artery disease. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | January 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00005554 | ||||
| Other Study ID Numbers ICMJE | 5098 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | December 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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