Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adenosine pre-medication, Standard care.
- Who it may be relevant to
- Registry conditions: ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow, Acute Myocardial Infarction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention: A Randomized Control Trial
Overview
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.
Detailed description
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.
Interventions
- Drug Adenosine pre-medication
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 a - Other Standard care
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 measures
- Primary Outcome [Time frame: During Procedure]
Eligibility criteria
Inclusion criteria
- All patients with acute STEMI undergoing primary PCI
- Patients of either sex, ≥18 years of age.
Exclusion criteria
- STEMI patients with cardiogenic shock at presentation
- Patients with heart block
- Allergy to adenosine
- Patients refuse to give consent for participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 2 centers
- National Institute of Cardiovascular Diseases — Karachi
- National Institute of Cardiovascular Diseases — Karachi
Identifiers
NCT: NCT07536802 · NICVDPakistan