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NCT07898696
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
Conditions: ST-Elevation Myocardial Infarction (STEMI)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 660
Sponsor: Prof Muzaffar Ali Zahidi
Location: Punjab institute of cardiology Lahore Lahore Punjab Province
Summary
The REFLOW AMI Trial aims to determine whether prophylactic high-dose intracoronary adenosine reduces slow-flow or no-reflow (SNR) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).
Slow-flow or no-reflow occurs when blood flow to the heart muscle remains reduced despite treatment of the blocked coronary artery. This complication can lead to greater heart muscle damage and worse clinical outcomes.
The study will evaluate a protocol involving 200 micrograms of intracoronary adenosine administered before each balloon or stent inflation during PPCI. Researchers will compare outcomes with standard PPCI care without prophylactic adenosine.
The main questions the study aims to answer are:
* Does prophylactic intracoronary adenosine reduce the incidence of slow-flow or no-reflow after PPCI?
* Does the protocol improve post-PCI coronary blood flow, assessed by TIMI flow grade and myocardial blush grade?
* What are the rates of major adverse cardiovascular events (MACE) during hospitalization and at 30 days?
* Does the protocol affect left ventricular ejection fraction (LVEF) at discharge and at 30 days?
* Does the protocol improve functional capacity at 30 days, assessed by the six-minute walk test?
* Is the prophylactic adenosine protocol safe?
Participants will undergo PPCI according to their assigned study group and will be assessed for angiographic outcomes, safety events, and clinical outcomes during hospitalization and follow-up, including at 30 days.
Eligibility Criteria
Inclusion Criteria;
* 18 years and older of either gender
* Diagnosis of STEMI
* Undergoing primary PCI
Exclusion Criteria:
* Cardiogenic shock
* Severe hypotension (SBP \
Source: ClinicalTrials.gov (NCT07898696). StuddyBuddy aggregates publicly available trial information.