Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment distal protection and drug eluting stent
Sponsor Rigshospitalet, Denmark
Start date May 2005
End date November 2009
Trial size 600 participants
Trial identifier NCT00192868, DEDICATION

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
ST segment resolution
time frame: 90 min
Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
time frame: immediately after and at 8 month follow up

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
Principal investigator Henning Kelbaek, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.