Clinical trial NCT06847568: 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
Official title: Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: ST Segment Elevation Myocardial Infarction (STEMI)
No Reflow Phenomenon
Keywords: STEMI
No-reflow
Adrenaline
Prophylaxis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: No-relow
timeFrame: 1 year up to 2 years
measure: No-relow
timeFrame: 1 year up to 2 years
Secondary outcomes:
measure: MACE
timeFrame: 1 year up to 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Ain Shams Univesity
Study officials:
References: