Acute Myocardial Infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10000930 Term: Acute myocardial infarction, unspecified site, initial episode of care System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: ADENOSINE
Product Name: ADENOSINE
Product Code: 19361
Pharmaceutical Form: Infusion
INN or Proposed INN: Adenosine
Other descriptive name: ADENOSINE
Concentration unit: mg/ml milligram(s)/
Sponsors
Västra Götalandsregionen, Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. A clinical diagnosis of anterior STEMI 3. Symptom duration =6 hours 4. Written informed consent obtained Angiographic inclusion criteria a. Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA b. TIMI flow =2 in the culprit vessel Echocardiographic inclusion criteria c. Detectable hypo- or akinesia corresponding to =5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: 1. Previous randomization in the study 2. Any of the following contraindications for treatment with adenosine: a. Known pre-existing atrioventricular block grade =2 or sick sinus syndrome in patients without pacemaker. b. Known pre-existing elevation of intracranial pressure c. Treatment with dipyridamole within 24 hours of randomization d. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study objectives: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.;Secondary Objective: Not applicable;Primary end point(s): The resolution of myocardial stunning at 48 hours (StunningRes48h). ;Timepoint(s) of evaluation of this end point: At 48 hours after acute myocardial Infarction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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). ;Timepoint(s) of evaluation of this end point: At 1, 2, 3, 7, 14, 30 and /or 6 months after acute myocardial Infarction | — |
Countries
Sweden
Contacts
Public ContactKardiologensforskningsenhet
Västra Götalandsregionen, Sahlgrenska University Hospital
Outcome results
None listed