NCT06847568RecruitingPhase 3
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
Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 16 Feb 2025
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Ain Shams University
- Diseases
- Coronary artery disease
- NCT number
- NCT06847568
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 1 Apr 2024 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Age
- Age \< 18 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of medicine Ain Shams Univesity Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.