Ignite Creation Date:
2024-05-05 @ 9:19 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00868855
Status:
TERMINATED
Last Update Posted:
2017-12-13
First Post:
2009-03-19
Brief Title:
Tissue-Type Plasminogen Activator t-PA Release Predicts Major Adverse Cardiac Events MACE in Patients With Non-critical Coronary Artery Disease
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The Intracoronary Tissue-type Plasminogen Activator t-PA Release Predicts Major Adverse Cardiac Events in Patients With Non-critical Coronary Artery Disease
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease is the leading cause of death in USA Contemporary cardiac care has substantially reduced mortality and morbidity in patients with severe coronary artery disease However patients with mild to moderate coronary artery stenosis 70 stenosis often present in the future with life threatening acute coronary syndrome which carries significant mortality and morbidity It is difficult to predict outcomes in these patients before the events because the lack of complete understanding of the mechanisms underlying acute coronary syndrome and the lack of reliable markers that will predict major adverse cardiac events MACE Tissue-type plasminogen activator t-PA is released from endothelial cells and a major factor that prevent thrombosis in the coronary artery the cause of acute coronary syndrome Endothelial dysfunction impairs t-PA release Therefore we hypothesize that patients with impaired coronary artery t-PA release will have significantly higher risk for future MACE due to intrinsic fibrinolytic dysfunction that leads to increased thrombosis risk
To test this hypothesis we will determine whether intrinsic endothelial fibrinolytic dysfunction predicts MACE in patients with non-significant CAD The study will measure t-PA release mediated by bradykinin a major mediator for t-PA release This will involve infusion of bradykinin into left main coronary artery of individuals who have undergone routine cardiac catheterization clinically indicated We will take blood samples from the coronary sinus and measure t-PA and plasminogen activator inhibitor-1 antigen and activity levels
To test this hypothesis we will determine whether intrinsic endothelial fibrinolytic dysfunction predicts MACE in patients with non-significant CAD The study will measure t-PA release mediated by bradykinin a major mediator for t-PA release This will involve infusion of bradykinin into left main coronary artery of individuals who have undergone routine cardiac catheterization clinically indicated We will take blood samples from the coronary sinus and measure t-PA and plasminogen activator inhibitor-1 antigen and activity levels
Detailed Description:
Tissue-type Plasminogen Activator tPA is a protein in the blood which breaks down clots and plays an important role in preventing myocardial infarction It is produced by the endothelial cell lining of the blood vessels Previous studies demonstrate that t-PA is released in response to the hormones bradykinin and acetylcholine Impaired t-PA release upon bradykinin stimulation may indicate endothelial dysfunction that leads to the development of acute coronary syndrome In this project we will determine whether impaired t-PA release can predict future occurrence of acute coronary syndrome The study will involve individuals getting routine left heart cardiac catheterizations indication for cardiac catheterization is solely based on clinical indication Prior to the procedure patient will have two blood samples 5 ml each collected from their forearm before and after 2 minutes blood pressure cuff inflation on their arm After routine diagnostic cardiac catheterization and there is no severe coronary artery stenosis 70 stenosis research protocol will be initiated Study includes infusion with increasing doses of bradykinin into their left main coronary artery and sample small amounts of blood from their coronary sinus 15 ml total
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P5OHL081009-02 | OTHER | NIHLB | None |