RecruitingACTRN12619001449123

Assessment of Inflammatory mediator release, microvascular resistance, and plaque morphology after percutaneous coronary intervention in patients treated with colchicine.


Sponsor

The Heart Research Institute

Enrollment

25 participants

Start Date

Jun 25, 2020

Study Type

Interventional

Conditions

Summary

This study first aims to evaluate whether there are differences between patients requiring stenting who have stable blockages in their coronary arteries versus those who present with unstable heart attacks. We hope to examine whether are difference in blood clotting (platelets in particular), release of inflammation markers (neutrophil-derived in particular), resistance to blood flow in the tiny capillaries of the heart muscle (microvascular resistance), and finally in morphology and composition of the culprit blockage or plaque as assessed by a technique named optical coherence tomography (OCT). In the unstable heart attack group in particular, we will also assess whether patients treated pre-procedurally with colchicine will demonstrate changes in these parameters compared to untreated controls. The purpose of the study is to identify whether colchicine could serve as a potential therapeutic option in these high-risk patients and improve outcomes by limiting adverse events such as further heart attack at the time of stenting (peri-procedural myocardial infarction). We hypothesise that levels of inflammation will be higher in unstable heart attack patients compared to patients with stable blockages, and that colchicine will attenuate the release of inflammatory products. We also hypothesise that in the unstable heart attack patients, there will be greater dysfunction in the microvessels of the heart and that this will correlate with inflammatory release and blood platelet adhesiveness, as well as with high-risk features of the culprit blockage/plaque as assessed by OCT.


Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Plain Language Summary

Simplified for easier understanding

When a blocked coronary artery is opened up with a stent procedure (called percutaneous coronary intervention or PCI), there can be an inflammatory reaction that causes further damage to the small blood vessels of the heart. This study is investigating whether giving the anti-inflammatory drug colchicine before the procedure can reduce this inflammation and related damage — and ultimately lower the risk of complications such as a small heart attack caused by the procedure itself. The study will examine differences in inflammation levels, blood clotting, and the microscopic structure of artery blockages between patients with stable coronary artery disease and those having emergency procedures for heart attacks. In the heart attack group, some participants will receive colchicine before their procedure and others will not, and various measurements will be taken to compare outcomes. You may be eligible if you are 21 or older, are having a cardiac catheterisation procedure at Royal Prince Alfred Hospital, and do not have severe blockage in the main coronary artery, cardiogenic shock, or kidney or liver problems. People who are pregnant, have active infections, or are already taking colchicine or anti-inflammatory drugs are not eligible. This study does not require any additional procedures beyond those you are already having as part of your cardiac care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will be prospectively recruited into this study, with approximately half with stable coronary disease and half with an acute coronary syndrome (ACS). In the ACS cohort, patients will be alloc

Patients will be prospectively recruited into this study, with approximately half with stable coronary disease and half with an acute coronary syndrome (ACS). In the ACS cohort, patients will be allocated in an alternating but non-randomised fashion to pre-procedural oral colchicine (1 mg then 0.5 mg one hour later) or no additional therapy. The intervention will be charted and delivered by study investigators, either on the ward or the cardiac day stay unit. In cardiac catheterisation laboratory, we will isolate peripheral and coronary sinus blood inflammatory cytokines, microparticles and platelets from patients. We will also correlate microparticle release and platelet adhesiveness in ACS after stenting with plaque morphology and microvascular dysfunction, by: A. Measuring the IMR with a pressure wire in the coronary artery. B. Imaging of the atherosclerotic plaque with intracoronary imaging technology - optical coherence tomography (OCT) In the stable cohort, we will collect peripheral and coronary sinus blood samples and perform OCT and IMR analysis but there will be no intervention arm, similar to the control group in the ACS cohort.


Locations(1)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

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ACTRN12619001449123


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