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
Recruiting
Phase 3Interventional Study
ST Segment Elevation Myocardial Infarction (STEMI)No Reflow Phenomenon
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,000 (estimated)
Sponsor
Ain Shams University · Other
Who this trial is looking for
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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 rece…
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.
Trial Locations
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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.
Exc…
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.
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