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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age < 18 years

Pregnant females.

Patients refused to give consent.

Patients who had normal coronary angiography.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Study (Adrenaline)Active comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

No-relow

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

Time frame
1 year up to 2 years
2

No-relow

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

Time frame
1 year up to 2 years

Secondary outcomes

1

MACE

Secondary end points will be major adverse cardiac events.

Time frame
1 year up to 2 years

Other outcomes

Sponsors and contacts

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