Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of medicine Ain Shams Univesity
RECRUITING
Cairo
Contact Information
Primary
Mostafa Abdallah Khalifa, Master cardiology
mostafaabdallahkhalifa@med.asu.edu.eg
+201012988025
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 1000
Treatments
Active_comparator: Study (Adrenaline)
This group will receive the all guidelines-directed recommendations of intervention in STEMI patients.~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.
No_intervention: Control
This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients.
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov