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

March 7, 2025 updated by: Mostafa AbdAllah Khalifa, Ain Shams University

Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of medicine Ain Shams Univesity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • Epinephrine
No Intervention: Control
This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No-relow
Time Frame: 1 year up to 2 years

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

Thrombolysis in Myocardial Infarction risk score (TIMI) flow grading system as following:

  • TIMI 0 = No ante-grade flow beyond the point of occlusion.
  • TIMI 1 = Faint ante-grade flow beyond the point of occlusion with incomplete filling of the distal vascular bed.
  • TIMI 2 = Delayed or sluggish ante-grade flow with complete filling of the distal vascular beds.
  • TIMI 3 = Normal flow with complete filling of the distal vascular bed

Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic TIMI flow is < 3
1 year up to 2 years
No-relow
Time Frame: 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
1 year up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 1 year up to 2 years
Secondary end points will be major adverse cardiac events.
1 year up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD48/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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