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
| NCT ID | NCT06847568 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ain Shams University |
| Condition | ST Segment Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2024-04-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06847568 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST Segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06847568 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT06847568 currently recruiting?
Yes, NCT06847568 is actively recruiting participants. Contact the research team at mostafaabdallahkhalifa@med.asu.edu.eg for enrollment information.
Where is the NCT06847568 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06847568 clinical trial?
NCT06847568 is sponsored by Ain Shams University. The trial plans to enroll 1,000 participants.