Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005554
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Biobehavioral Predictors of Coronary Angioplasty Outcome
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To examine some of the psychosocial predictors of poor outcome among revascularized coronary artery disease patients
Detailed Description:
BACKGROUND
Percutaneous coronary revascularization procedures are increasingly used in the treatment of coronary artery disease with approximately 300000 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 eg 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Percutaneous coronary revascularization procedures are increasingly used in the treatment of coronary artery disease with approximately 300000 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 eg 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL058638 | NIH | None | httpsreporternihgovquickSearchR29HL058638 |