An interventional study of Adenosine and Standard Treatment only in ST-Elevation Myocardial Infarction (STEMI), sponsored by Prof Muzaffar Ali Zahidi. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Prof Muzaffar Ali Zahidi · Not applicable, Interventional, and Treatment
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:
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.
692 studies on the registry are indexed under ST Elevation Myocardial Infarction; 186 are open to participants now.
This study's planned enrollment of 660 is above the median of 194 across 441 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →This is the only study on the registry with Prof Muzaffar Ali Zahidi as lead sponsor.
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Exclusion Criteria:
Intracoronary adenosine (200µg) injected in less than thirty seconds just before each balloon or stent inflation.
Drug: Adenosine
Participants receive standard treatment for ST-elevation myocardial infarction (STEMI), including primary percutaneous coronary intervention (PCI) and guideline-directed medical therapy, according to institutional protocols. No placebo is administered.
Other: Standard Treatment only
Prophylactic administration of 200 micrograms of intracoronary adenosine immediately before each balloon inflation or stent deployment during primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). Adenosine is administered rapidly, within less than 30 seconds before each inflation, according to the study protocol. No additional vasodilator agents are used as part of this prophylactic protocol. The intervention is intended to reduce coronary slow-flow/no-reflow and improve post-PCI myocardial perfusion.
Placebo administered according to the study protocol alongside standard treatment for patients undergoing primary PCI for STEMI in control group
Incidence of Slow-Flow or No-Reflow After PPCI
The proportion of participants with slow-flow or no-reflow on final post-PCI angiography, assessed using the Thrombolysis in Myocardial Infarction (TIMI) flow grade. Slow-flow/no-reflow is defined as final TIMI flow grade 0, 1, or 2 in the treated infarct-related artery, in the absence of a mechanical cause of impaired coronary flow.
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Final TIMI Flow Grade
Thrombolysis in Myocardial Infarction (TIMI) Flow Grade ranges from 0 to 3. Grade 0 indicates no antegrade coronary flow, while Grade 3 indicates normal coronary flow. Higher scores indicate better coronary blood flow.
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Myocardial Blush Grade After Primary PCI
Myocardial Blush Grade ranges from 0 to 3. Grade 0 indicates no myocardial blush, while Grade 3 indicates normal myocardial perfusion. Higher scores indicate better myocardial perfusion.
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1)
Incidence of Major Adverse Cardiovascular Events (MACE)
Proportion of participants experiencing a major adverse cardiovascular event, defined according to the study protocol as death, periprocedural myocardial infarction, or target-vessel revascularization (TVR). Events will be assessed during the index hospitalization and through 30 days after PCI.
Time frame: At the time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Safety of Prophylactic High-Dose Intracoronary Adenosine
Incidence of adverse events associated with the study intervention, including clinically significant bradycardia, atrioventricular block, hypotension, and other adverse events specified in the study protocol.
Time frame: During the primary PCI procedure, immediately after completion of PCI (Day 1) & at time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Left Ventricular Ejection Fraction at Discharge and 30 Days
Left ventricular ejection fraction (LVEF), expressed as a percentage, assessed using echocardiography at hospital discharge and at 30-day follow-up.
Time frame: At the time of Hospital Discharge (upto 10 Days) and at 30 days after PCI.
Six-Minute Walk Distance at 30 Days
Functional exercise capacity assessed by the six-minute walk test. The distance walked in meters during six minutes will be recorded at the 30-day follow-up visit.
Time frame: 30 days after PCI.
Plan to share: Yes — De-identified individual participant data underlying the published results will be made available, including demographic characteristics, baseline clinical features, procedural and angiographic data (including TIMI flow grade and myocardial blush grade), study intervention allocation, adverse events, major adverse cardiovascular events, left ventricular ejection fraction, and six-minute walk test results, where collected. Data will be shared without direct personal identifiers and subject to applicable ethical, institutional, and data-protection requirements.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Adenosine
ST Elevation Myocardial Infarction →