Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction

Not Applicable

• Conditions: Coronary Artery Disease

• Registration Number: NCT00192868
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-22
• Last Update Posted: 2009-09-23
• Primary Completion: 2009-11
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ST segment resolution	90 min
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

Secondary Outcome Measures

Name	Time	Method
wall motion index	During hospitalisation: day 3-5
Minimal lumen diameter	8 months
frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.	8 months
Occurrence of stent thrombosis and MACE.	12 months
Restenosis	8 months
maximal elevations in blood concentrations of CK-MB enzyme and troponin-T	Post procedure

Trial Locations

Locations (1)

Cardiac Cath Lab, Rigshospitalet; 🇩🇰 Copenhagen, Denmark