Skip to content

Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention

Adenosine Pre-Medication in Primary Percutaneous Coronary Intervention: A Randomized Control Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07536802
Acronym
AMPACT
Enrollment
1148
Registered
2026-04-17
Start date
2025-06-01
Completion date
2026-12-31
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Adenonsine, Primary Percutaneous Coronary Intervention (Primary PCI), ST-Segment Elevation Myocardial Infarction (STEMI), No-Reflow Phenomenon, Coronary Slow Flow, Myocardial Reperfusion

Brief summary

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

DRUGAdenosine 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 and Myocardial Blush Grade).

OTHERStandard 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.

Sponsors

National Institute of Cardiovascular Diseases, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary OutcomeDuring ProcedureSlow flow/no-reflow: will be categorized as final TIMI 0 to II flow

Countries

Pakistan

Contacts

CONTACTMuhammad Nauman Khan, FCPS
nkhan116@yahoo.com+923453549634
CONTACTKhalid Naseeb, FCPS
khalidnaseeb50@gmail.com+923002469284
PRINCIPAL_INVESTIGATORMuhammad Nauman, FCPS

National Institute of Cardiovascular Diseases

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026