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

NCT ID: NCT06847568

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Study (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.

Group Type: ACTIVE_COMPARATOR

Adrenaline

Intervention Type: DRUG

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adrenaline

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.

Intervention Type: DRUG

Other Intervention Names

Epinephrine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa AbdAllah Khalifa

Assistant lecturer of cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine Ain Shams Univesity

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mostafa Abdallah Khalifa, Master cardiology

Role: CONTACT

mostafaabdallahkhalifa@med.asu.edu.eg

+201012988025

Facility Contacts

Khaled Aly, Associate professor

Role: primary

Dr.khaled.aly@med.asu.edu.eg

201003593088

Other Identifiers

FMASU MD48/2024

Identifier Type: -

Identifier Source: org_study_id