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NCT Number: 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

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.

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Key information

Conditions

ST Segment Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis No Reflow Phenomenon No-Reflow Phenomenon Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of medicine Ain Shams Univesity

Cairo, Egypt

Location status: Recruiting

Location contact

Khaled Aly, Associate professor

CONTACT

[email protected]

201003593088

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are 18 years or older
  • 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

  • Age < 18 years
  • Pregnant females.
  • Patients refused to give consent.
  • Patients who had normal coronary angiography.
  • Patients who had CTO lesions.
  • Patients who have SCAD.
  • Patients who developed dissection or mechanical complication during the procedure.
  • Patients presenting with cardiogenic shock.
  • Cardiomyopathies
  • 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.

Treatment and study plan

Adrenaline

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.

Other names: Epinephrine

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. MACE

    Time frame: 1 year up to 2 years

    Secondary end points will be major adverse cardiac events.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Abdallah Khalifa, Master cardiology

CONTACT

[email protected]

+201012988025

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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