A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Melbourne
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Index of Microvascular Resistance
Study Overview
Brief Summary
Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction.
The investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.
Detailed Description
The index of microcirculatory resistance (IMR), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and ST elevation myocardial infarction. The glycoprotein IIb/IIIa receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. This study will investigate whether an intracoronary bolus of abciximab in patients with non-ST elevation myocardial infarction decreases IMR and improves microvascular function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with acute coronary syndromes
Exclusion Criteria
- •Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI
Arms & Interventions
Intracoronary abciximab (Reopro)
Intracoronary abciximab (Reopro)
Intervention: Abciximab (Drug)
Outcomes
Primary Outcomes
Index of Microvascular Resistance
Time Frame: within 3 hours
We will assess IMR in the catheterisation laboratory immediately before PCI, then intracoronary reopro or placebo will be administered and we will re-assess IMR 15 minutes post delivery of the study drug. Finally we will perform PCI and immediately measure IMR post-procedure.
Secondary Outcomes
- Incidence of periprocedural myocardial infarction(within 24 hours)
Investigators
A/P Andrew Wilson
Associate Professor
University of Melbourne