A Phase 4 interventional study of Adenosine pre-medication and Standard care in ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon and Coronary Slow Flow, sponsored by National Institute of Cardiovascular Diseases, Pakistan. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by National Institute of Cardiovascular Diseases, Pakistan · Phase 4, Interventional, and Treatment
Primary objective of the study is to evaluate the impact of adenosine pre-medication on incidence of slow flow/no-reflow after primary percutaneous coronary intervention.
Background:
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for ST-segment elevation myocardial infarction (STEMI); however, optimal myocardial perfusion is not achieved in all patients due to the slow flow/no-reflow phenomenon. This condition, defined as inadequate myocardial perfusion despite patent epicardial arteries, is associated with worse clinical outcomes. Adenosine, owing to its vasodilatory, anti-inflammatory, and antiplatelet properties, may improve microvascular perfusion. While its use during PCI is established, its prophylactic role prior to PCI remains unclear.
Study Design:
This is a multicenter, single-blinded, randomized controlled trial conducted at NICVD Karachi and its satellite centers (Liyari and Larkana) over 12 months. A total of 1,148 STEMI patients undergoing primary PCI will be randomized in a 1:1 ratio using block randomization.
Intervention:
Intervention Group: Intracoronary adenosine pre-medication (2 mg for left coronary artery, 1 mg for right coronary artery, diluted in 20 mL normal saline) plus standard care.
Control Group: Standard pharmacological management alone.
Participants:
Adults (≥18 years) with STEMI undergoing primary PCI. Key exclusions include cardiogenic shock, heart block, adenosine allergy, and refusal to consent.
Outcomes:
Primary Outcome: Incidence of slow flow/no-reflow (TIMI flow grade 0-II). Secondary Outcome: Myocardial Blush Grade (0-III).
Safety:
Potential adverse effects such as transient bradycardia or heart block will be managed per institutional protocols.
Data and Analysis:
Baseline, procedural, and outcome data will be collected. Statistical analysis will be performed using SPSS, with appropriate tests applied for continuous and categorical variables. A p-value ≤0.05 will be considered significant.
Exclusion Criteria:
Patients will receive intracoronary adenosine prior to primary PCI: Dose: 2 mg for left coronary artery, 1 mg for right coronary artery Dilution: 20 mL normal saline Route: Intracoronary (proximal via guide or distal via device) Purpose: To reduce incidence of slow flow/no-reflow and improve myocardial perfusion. Other Names: Adenocard (if needed for registry consistency)
Drug: Adenosine pre-medication · Other: Standard care
Patients will undergo primary PCI with standard pharmacological therapy, without adenosine pre-medication. Purpose: Serve as comparator to evaluate the effect of adenosine pre-medication.
Other: Standard care
Patients will receive intracoronary adenosine before primary PCI in addition to standard pharmacological therapy: Dose: 2 mg for left coronary artery, 1 mg for right coronary artery Dilution: 20 mL normal saline Route: Intracoronary (proximal via guide catheter or distal via delivery device) Timing: Administered immediately prior to PCI Purpose: To evaluate whether adenosine pre-medication reduces the incidence of slow flow/no-reflow and improves myocardial perfusion outcomes (TIMI flow grade and Myocardial Blush Grade).
Patients will receive standard pharmacological management during primary PCI without adenosine pre-medication. Purpose: Serves as the control to assess the effect of adenosine on slow flow/no-reflow and myocardial perfusion.
Primary Outcome
Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow
Time frame: During Procedure
Plan to share: No
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ST Elevation Myocardial Infarction→
National Institute of Cardiovascular Diseases, Pakistan