NCT07536802

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,148

participants targeted

Target at P75+ for phase_4

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 10, 2026

Last Update Submit

April 17, 2026

Conditions

ST-Segment Elevation Myocardial Infarction (STEMI)No-Reflow PhenomenonCoronary Slow FlowAcute Myocardial Infarction

Keywords

AdenonsinePrimary Percutaneous Coronary Intervention (Primary PCI)ST-Segment Elevation Myocardial Infarction (STEMI)No-Reflow PhenomenonCoronary Slow FlowMyocardial Reperfusion

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    Slow flow/no-reflow: will be categorized as final TIMI 0 to II flow

    During Procedure

Study Arms (2)

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)

Drug: Adenosine pre-medicationOther: Standard care

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.

Other: Standard care

Interventions

Adenosine pre-medicationDRUG

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).

Intervention Group (Adenosine Pre-Medication + Standard Care)
Standard careOTHER

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.

Control Group (Standard Care Alone)Intervention Group (Adenosine Pre-Medication + Standard Care)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with acute STEMI undergoing primary PCI
  • Patients of either sex, ≥18 years of age.

You may not qualify if:

  • STEMI patients with cardiogenic shock at presentation
  • Patients with heart block
  • Allergy to adenosine
  • Patients refuse to give consent for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

RECRUITING

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNo-Reflow Phenomenon

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Muhammad Nauman, FCPS

    National Institute of Cardiovascular Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Nauman Khan, FCPS

CONTACT

+923453549634nkhan116@yahoo.com

Khalid Naseeb, FCPS

CONTACT

+923002469284khalidnaseeb50@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 17, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)