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
  Purpose

To examine some of the psychosocial predictors of poor outcome among revascularized coronary artery disease patients.


Condition
Cardiovascular Diseases
Heart Diseases
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Defined Population

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1999
Estimated Study Completion Date: January 2004
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005554

Sponsors and Collaborators
Investigators
Investigator: Willem Kop Uniform Services University of Health Sciences
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005554     History of Changes
Other Study ID Numbers: 5098
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 30, 2014