Improve the myocardial reperfusion in ST elevation myocardial infarction: a randomized study between thrombectomy and pharmacological approach guided by the angiographic evidence of thrombus
- Conditions
- ST elevation myocardial infarctionMedDRA version: 17.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-005369-64-ES
- Lead Sponsor
- Consorci MAr Parc de Salut de Barcelona
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-Chest pain suggestive of myocardial ischemia for at least 30 minutes
-Symptoms onset less than 12 hours before hospital admission
-ST segment elevation of at least 1 mm in two or more contiguous leads (>o = 2mm in precordial leads)
-To understand and accept the study procedures and signed informed consent
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
-ST elevation myocardial infarction presenting with cardiogenic shock
-Previous myocardial infarction (< 6 months)
-Formal contraindication to thrombolysis or to prasugrel
-Patients on oral anticoagulation therapy
-Patients treated with vitamin K, bivalirudin or fondaparinux
-Patients with severe renal failure (glomerular filtration rate <30ml/min/m2)
-Patients with contraindication to study medications, which cannot be managed medically, including: adenosine, heparin, IIb-IIIa inhibitors, contrast agents, clopidogrel, ticagrelor, prasugrel or aspirin
-Known life-threatening disease with a life expectancy of <12 months
-Inability to obtain informed consent
-Patients with contraindications to cardiovascular magnetic resonance
-Pregnant or breastfeeding patient
-Allergic reaction to the product (Methylase) and/or excipient
-Patients presenting with pace rhytm, preexcitation or other conditions or artifacts interfering with the interpretation of ST segment resolution
-Patient presenting with second or third degree of atrioventricular block or need of temporal pacemarker
-Culprit lesion located in small segments or secundary branches <2.5 mm diameter
-Impossibility to advance thrombectomy/Amicath device due to extreme tortuosy or calcification
-Significant left main disease
-Thrombolysis in myocardial infarction (TIMI) flow 3 without the visualization of intracoronary thrombus at initial angiography
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method