- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00868855
Tissue-Type Plasminogen Activator (t-PA) Release Predicts Major Adverse Cardiac Events (MACE) in Patients With Non-critical Coronary Artery Disease
The Intracoronary Tissue-type Plasminogen Activator (t-PA) Release Predicts Major Adverse Cardiac Events in Patients With Non-critical Coronary Artery Disease
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >18 year old male and female patients
- All patients are referred for elective cardiac catheterization based on clinical indication
- Cath shows mild or moderate (<70% stenosis) CAD that does not require mechanical intervention
Exclusion Criteria:
- Severe stenosis requires intervention.
- Significant left main coronary artery disease (>40%).
- Acute MI or acute coronary syndrome with enzyme elevation or ischemic EKG changes
- Patients with severe left ventricular dysfunction (EF<35%)
- Prior history of myocardial infarction
- History of stroke within 3 months.
- Recent history of thrombolytic
- History of coronary intervention within previous 6 months.
- Patients with history of coronary spasm
- Patients with congestive heart failure (class III and IV).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Bradykinin
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Bradykinin, 0.2 ug - 2ug/minute, one time intracoronary infusion over 6 minutes.
Drug (bradykinin) will be infused into the left main coronary artery via diagnostic catheter (JL4) at an escalating rate of 0.2, 0.6, 2 g/ml (1ml/min).
A 5F Multipurpose catheter will be advanced to coronary sinus for blood sampling.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Douglas Vaughn, MD, Northwestern University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Cysteine Proteinase Inhibitors
- Bradykinin
- Kininogens
Other Study ID Numbers
- IRB# 030473
- 5P5OHL081009-02 (Other Identifier: NIHLB)
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