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RecruitingNCT06847568

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
1,000 (estimated)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAdrenalineIntracoronary 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.

Timeline

Start date
2024-04-01
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2025-02-26
Last updated
2025-03-11

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06847568. Inclusion in this directory is not an endorsement.