Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2026-01-05 @ 10:06 PM
Study NCT ID:
NCT05014061
Status:
WITHDRAWN
Last Update Posted:
2024-05-17
First Post:
2021-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction An Open-label, Single Center Trial
Status:
WITHDRAWN
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
A-STAMI
Brief Summary:
The aim of this study is to evaluate the effect of adenosine on the recovery of myocardial akinesia in ST-elevation myocardial infarction (STEMI). The study is a single-center randomized clinical trial intending to include 90 patients.
The objective of the study is to investigate whether treatment with adenosine hastens recovery of myocardial akinesia and improves cardiac function at 48 hours in patients with STEMI.
The objective of the study is to investigate whether treatment with adenosine hastens recovery of myocardial akinesia and improves cardiac function at 48 hours in patients with STEMI.
Detailed Description:
Primary endpoint (variable):
The resolution of myocardial stunning at 48 hours (StunningRes48h).
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula:
StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
Secondary endpoint(s) (variables):
1. Infarct size at 6 months, as assessed by cardiac magnetic resonance imaging (magnetic resonance imaging).
2. Ejection fraction days 1, 2, 3, 7, 14, 30 and 6 months.
3. Any sustained ventricular tachycardia or fibrillation within 72 hours (safety endpoint; binary)
4. Any high-grade atrioventricular block or sinus arrest within 72 hours (safety endpoint; binary)
5. Implantation of cardiac assist device within 72 hours (binary)
6. Stroke within 6 months (binary)
7. All-cause mortality within 6 months
8. Heart failure rehospitalization within 6 months\*
9. Worsening in-hospital heart failure ≥12 hours after PCI#
10. Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months.
* Defined as re-admission to hospital after discharge, with a total length of admission ≥24 hours, documented worsening of heart failure signs or symptoms (e.g. worsening dyspnea, fatigue, edema/fluid overload, pulmonary venous distension or signs of pulmonary edema on X-ray), with administration of intravenous diuretic or inotropic drugs, ultrafiltration, non-invasive ventilation or mechanical assist device.
* Defined as intensification of heart failure therapy due to worsening heart failure signs or symptoms (as above; including intravenous diuretic, inotropic or vasopressor drugs, non-invasive ventilation or mechanical assist device).
The resolution of myocardial stunning at 48 hours (StunningRes48h).
The proportion of stunning that has resolved at 48 hours will be calculated according to the formula:
StunningRes48h = (%AkinesiaBaseline - %Akinesia48h) / (%AkinesiaBaseline - %Akinesia30days) where %AkinesiaT is defined as the endocardial length of the akinetic myocardium measured in end-diastole divided by the total endocardial length measured in end-diastole in the 2- and 4-chamber view, at time T (T= 48h or 30 days)
Secondary endpoint(s) (variables):
1. Infarct size at 6 months, as assessed by cardiac magnetic resonance imaging (magnetic resonance imaging).
2. Ejection fraction days 1, 2, 3, 7, 14, 30 and 6 months.
3. Any sustained ventricular tachycardia or fibrillation within 72 hours (safety endpoint; binary)
4. Any high-grade atrioventricular block or sinus arrest within 72 hours (safety endpoint; binary)
5. Implantation of cardiac assist device within 72 hours (binary)
6. Stroke within 6 months (binary)
7. All-cause mortality within 6 months
8. Heart failure rehospitalization within 6 months\*
9. Worsening in-hospital heart failure ≥12 hours after PCI#
10. Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months.
* Defined as re-admission to hospital after discharge, with a total length of admission ≥24 hours, documented worsening of heart failure signs or symptoms (e.g. worsening dyspnea, fatigue, edema/fluid overload, pulmonary venous distension or signs of pulmonary edema on X-ray), with administration of intravenous diuretic or inotropic drugs, ultrafiltration, non-invasive ventilation or mechanical assist device.
* Defined as intensification of heart failure therapy due to worsening heart failure signs or symptoms (as above; including intravenous diuretic, inotropic or vasopressor drugs, non-invasive ventilation or mechanical assist device).
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?: