The Investigator Administers Intracoronary Adrenaline Via the Catheter in STEMI Patients During Primary PCI, After Flow Restoration and Before Stenting, and Studies Its Effect in Prevention of No Reflow

Phase 3

Recruiting

• Conditions: ST Segment Elevation Myocardial Infarction (STEMI); No Reflow Phenomenon
• Interventions: Drug: Adrenaline

• Registration Number: NCT06847568
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this work is to study the role of intracoronary adrenaline administration as a preventive tool for no reflow in patients undergoing primary PCI.

The main question it aims to answer is:

Do prohylcatic intrcoronary adrenaline reduce the incidence of no reflow without increaing risk of arrhythmia in primary PCI?

The procedure will be performed by expert operators. All patients will receive the guidelines-directed recommendations of intervention of STEMI patients.

Study group wil receive Intracoronary 10 mcg adrenaline via the guiding catheter after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting.

All steps in the Cath-lab will be described in detail:

The primary end points will be improvement in coronary flow, as assessed by TIMI (Thrombolysis in Myocardial Infarction) flow, and myocardial blush.

Secondary end points will be in-hospital mortality and major adverse cardiac events.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients who are 18 years or older
2. Patients presenting with acute coronary syndrome with ECG criteria diagnostic of STEMI (according to the universal definition of myocardial infarction) within 12 hours from the onset of symptoms and treated by successful primary PCI.

Exclusion Criteria

1. Age < 18 years
2. Pregnant females.
3. Patients refused to give consent.
4. Patients who had normal coronary angiography.
5. Patients who had CTO lesions.
6. Patients who have SCAD.
7. Patients who developed dissection or mechanical complication during the procedure.
8. Patients presenting with cardiogenic shock.
9. Cardiomyopathies
10. Contraindications to epinephrine as HTN with SBP >180 mmHg or DBP>110 mmHg, clinically significant arrhythmia (Atrial fibrillation with rapid ventricular rate, ventricular tachycardia, or ventricular fibrillation) prior to PCI, known allergy to epinephrine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study (Adrenaline)	Adrenaline	This group will receive the all guidelines-directed recommendations of intervention in STEMI patients. Intracoronary 10 mcg adrenaline will be given via the guiding catheter in study group after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting.

Primary Outcome Measures

Name	Time	Method
No-relow	1 year up to 2 years	The primary end points will be improvement in coronary flow, as assessed by myocardial blush grade.; Myocardial blush grade (MBG) is defined as: * MBG 0 = No myocardial blush or contrast density.; * MBG 1 = Minimal myocardial blush or contrast density.; * MBG 2 = Moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsi-lateral non-infarct-related coronary artery.; * MBG 3 = Normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery; Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic MBG is 0 or 1

Secondary Outcome Measures

Name	Time	Method
MACE	1 year up to 2 years	Secondary end points will be major adverse cardiac events.

Trial Locations

Locations (1)

Faculty of medicine Ain Shams Univesity; 🇪🇬 Cairo, Egypt