Administering adrenaline in STEMI patients during PCI to prevent no reflow
Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
PHASE3 · Ain Shams University · NCT06847568
This study tests if giving adrenaline during heart procedures can help STEMI patients avoid complications with blood flow without causing heart rhythm problems.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06847568 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the administration of intracoronary adrenaline in patients with ST Segment Elevation Myocardial Infarction (STEMI) during primary percutaneous coronary intervention (PCI). The study aims to determine if prophylactic use of adrenaline can reduce the incidence of no reflow without increasing the risk of arrhythmias. Patients will receive adrenaline after restoring coronary flow and before stenting, with expert operators performing the procedure. The primary endpoint is the improvement in coronary flow assessed by TIMI flow grading.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with acute coronary syndrome and diagnosed with STEMI within 12 hours of symptom onset.
Not a fit: Patients who may not benefit include those under 18, pregnant women, and individuals with contraindications to epinephrine or other serious cardiac conditions.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of no reflow in STEMI patients, improving their outcomes post-PCI.
How similar studies have performed: While the use of adrenaline in this context is being explored, similar studies have shown promise in improving coronary flow, making this approach potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Faculty of medicine Ain Shams Univesity — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mostafa Abdallah Khalifa, Master cardiology
- Email: mostafaabdallahkhalifa@med.asu.edu.eg
- Phone: +201012988025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ST Segment Elevation Myocardial Infarction, No Reflow Phenomenon, STEMI, No-reflow, Adrenaline, Prophylaxis