Tissue-Type Plasminogen Activator (t-PA) Release Predicts Major Adverse Cardiac Events (MACE) in … (NCT00868855) | Clinical Trial Compass
TerminatedPhase 1
Tissue-Type Plasminogen Activator (t-PA) Release Predicts Major Adverse Cardiac Events (MACE) in Patients With Non-critical Coronary Artery Disease
Stopped: poor enrollment
United States16 participantsStarted 2003-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you help me understand why it was stopped early, and what that means for the reliability of any findings about t-PA release and heart event risk?
2Since this was a Phase 1 study focused on whether t-PA release can predict future cardiac events, does that mean it was still in very early stages of testing this approach, and is there stronger evidence available from more advanced research I should know about?
3The trial measured mortality as its primary outcome in people with non-critical coronary artery disease — does my specific situation fall into that 'non-critical' category, and how does that affect which monitoring or treatment options make sense for me?
4Given that this trial has been terminated, are there currently active studies or updated clinical approaches for predicting major adverse cardiac events in coronary artery disease patients that might be worth exploring instead?
5How does measuring t-PA release as a predictor compare to the standard tests and risk assessments you already use for my condition — is this something that would change how you'd manage my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.