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Recruiting NCT07536802

Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention

Phase IV Interventional ST-Segment Elevation Myocardial Infarction (STEMI) No-Reflow Phenomenon Coronary Slow Flow Acute Myocardial Infarction

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗