Coronary Artery Disease Clinical Trial
Official title:
Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
Verified date | September 2009 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.
Status | Active, not recruiting |
Enrollment | 600 |
Est. completion date | November 2011 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Acute onset typical chest pain of < 12 hours' duration - ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram - High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire - Possibility to perform distal protection of the infarct-related artery Exclusion Criteria: - History of previous myocardial infarction - Use of fibrinolytic agents for the index infarction - Left main stenosis - Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route - Known renal failure - Other significant cardiac disease - Other severe disease with an expected survival < 1 year - Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication - Linguistic difficulties needing an interpreter - Gastrointestinal bleeding within 1 month - Childbearing potential or pregnancy - Participation in another study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Cardiac Cath Lab, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ST segment resolution | 90 min | No | |
Primary | Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up). | immediately after and at 8 month follow up | No | |
Secondary | Restenosis | 8 months | No | |
Secondary | maximal elevations in blood concentrations of CK-MB enzyme and troponin-T | Post procedure | No | |
Secondary | wall motion index | During hospitalisation: day 3-5 | No | |
Secondary | Minimal lumen diameter | 8 months | No | |
Secondary | frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment. | 8 months | No | |
Secondary | Occurrence of stent thrombosis and MACE. | 12 months | Yes |
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