A Phase 3 interventional study of Adenosine in Myocardial Ischemia, sponsored by Vastra Gotaland Region. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Vastra Gotaland Region · Phase 3, Interventional, and Other
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.
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):
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
Browse Myocardial Infarction studies →Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Written informed consent obtained - Angiographic Inclusion criteria:
TIMI flow ≤2 in the culprit vessel
-Echocardiographic inclusion criteria:
Exclusion Criteria:
Any of the following contraindications for treatment with adenosine:
Adenosine infusion 70 µg/kg/min initiated prior to revascularization and maintained for 6 hours
Drug: Adenosine
Standard of care
Adenosine infusion 70 µg/kg/min for 6 hours
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)
Time frame: 48 hours
Infarct size
Infarct size, assessed by cardiac magnetic resonance imaging
Time frame: 6 months
Ejection fraction
Ejection fraction, assessed by echocardiography
Time frame: Day 1, Day 2, Day 3, Day 7, Day 14, Day 30 and 6 months
Sustained ventricular tachycardia or fibrillation
Any sustained ventricular tachycardia or fibrillation within 72 hours
Time frame: 72 hours
High-grade atrioventricular block or sinus arrest
Any high-grade atrioventricular block or sinus arrest within 72 hours
Time frame: 72 hours
Cardiac assist device
Implantation of cardiac assist device within 72 hours
Time frame: 72 hours
Stroke
Stroke within 6 months
Time frame: 6 months
Mortality
All-cause mortality within 6 months
Time frame: 6 months
Rehospitalization
Heart failure rehospitalization within 6 months
Time frame: 6 months
Worsening heart failure
Worsening in-hospital heart failure after PCI
Time frame: ≥12 hours
Composite
Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months
Time frame: ≥12 hours or 6 months
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Vastra Gotaland Region