Clinical trial

Adenosine's Effect on STunning Resolution in Acute Myocardial Infarction An Open-label, Single Center Trial

Name
EudraCT number: 2021-001466-37
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2025-06-01
Trial end
2025-12-01
Status
Withdrawn
Phase
Early phase I
Treatment
Adenosine
Adenosine infusion 70 µg/kg/min for 6 hours
Arms:
Adenosine
Primary endpoint
The resolution of myocardial stunning at 48 hours (StunningRes48h).
48 hours
Eligibility criteria
Inclusion Criteria: 1. Age \>18 years. 2. Anterior STEMI. 3. Symptom duration ≤6 hours 4. Written informed consent obtained - Angiographic Inclusion criteria: 1. Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA 2. TIMI flow ≤2 in the culprit vessel -Echocardiographic inclusion criteria: 3. Detectable hypo- or akinesia corresponding to ≥5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment. Exclusion Criteria: 1. Previous randomization in the study 2. Any of the following contraindications for treatment with adenosine: 1. Known pre-existing atrioventricular block grade ≥2 or sick sinus syndrome in patients without pacemaker. 2. Known pre-existing elevation of intracranial pressure 3. Treatment with dipyridamole within 24 hours of randomization 4. Systolic blood pressure \<80 mm Hg at screening 3. Any concomitant condition resulting in a life expectancy of less than one month 4. Previous myocardial infarction or other cardiac condition resulting in impaired regional or global systolic function without documented recovery of cardiac function 5. Heart transplant or left ventricular assist device recipient 6. Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis or characteristics that may interfere with adherence to the trial protocol 7. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single center, open-label, randomized controlled trial', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-05-17

1 organization

1 product

1 indication

Product
Adenosine