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

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: No Reflow Phenomenon; ST Segment Elevation Myocardial Infarction (STEMI)

Treatments: Drug: Adrenaline

Study type: Interventional

Funder types: Other

Identifiers

NCT06847568

FMASU MD48/2024

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,000 participants in 2 patient groups

Study (Adrenaline)

Active Comparator group

Description:

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.

Treatment:

Drug: Adrenaline

Control

No Intervention group

Description:

This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients.