Status:
UNKNOWN
Optimizing Infarct Size by Transforming Emergent Stenting Into an Elective Procedure Study
Lead Sponsor:
Marco Valgimigli
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perf...
Detailed Description
In the setting of largely thrombotic lesions such as those treated in the context of primary PCI, stenting often results in distal micro and macro-embolisation which hampers coronary flow and microvas...
Eligibility Criteria
Inclusion
- chest pain for \>30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block
- admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia
Exclusion
- the exclusion criteria will include history of bleeding diathesis or documented allergy/intolerance or contraindication to clopidogrel or ticlopidine or prasugrel
- inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin
- uncontrolled hypertension (systolic or diastolic arterial pressure \>180 mmHg or 120, respectively, despite medical therapy)
- limited life expectancy, e.g. neoplasms, others
- inability to obtain informed consent
- pregnancy
- patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to CMR (claustrophobia, pacemakers, or implantable defibrillator devices)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01462188
Start Date
October 1 2011
End Date
October 1 2015
Last Update
October 31 2011
Active Locations (1)
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1
U.O. Cardiologia
Ferrara, Emilia-Romagna, Italy, 44100