Biobehavioral Predictors of Coronary Angioplasty Outcome

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005554
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: December 2004

May 25, 2000
June 23, 2005
February 1999
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Complete list of historical versions of study NCT00005554 on ClinicalTrials.gov Archive Site
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Biobehavioral Predictors of Coronary Angioplasty Outcome
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To examine some of the psychosocial predictors of poor outcome among revascularized coronary artery disease patients.

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.

Observational
Observational Model: Defined Population
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  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2004
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005554
5098
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Willem Kop Uniform Services University of Health Sciences
National Heart, Lung, and Blood Institute (NHLBI)
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP