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

Coronary Artery Disease Clinical Trial

Official title:

Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00192868
• Other study ID #: DEDICATION
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 22, 2009
• Start date: May 2005
• Est. completion date: November 2011

Study information

• Verified date: September 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• Distal protection and drug eluting stent

Locations

Country	Name	City	State
Denmark	Cardiac Cath Lab, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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