Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2025-12-24 @ 12:59 PM
NCT ID:
NCT05014061
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.
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).
Study:
NCT05014061
Study Brief:
Protocol Section:
NCT05014061