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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Adenosine Pre-Medication + Standard Care) | Experimental | 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) |
|
| Control Group (Standard Care Alone) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine pre-medication | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow | During Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Nauman Khan, FCPS | Contact | +923453549634 | nkhan116@yahoo.com | |
| Khalid Naseeb, FCPS | Contact | +923002469284 | khalidnaseeb50@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Nauman, FCPS | National Institute of Cardiovascular Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiovascular Diseases | Recruiting | Karachi | Sindh | 75510 | Pakistan |
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|
| Standard care | Other | 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. |
|
| National Institute of Cardiovascular Diseases | Recruiting | Karachi | Sindh | 75510 | Pakistan |
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D054318 | No-Reflow Phenomenon |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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