Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-01-02 @ 2:57 AM
Study NCT ID:
NCT06847568
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: