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

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ClinicalTrials.gov Identifier: NCT00192868
Recruitment Status : Unknown
Verified September 2009 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : September 23, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Distal protection and drug eluting stent

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
Study Start Date : May 2005
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. ST segment resolution [ Time Frame: 90 min ]
  2. 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 Outcome Measures :
  1. Restenosis [ Time Frame: 8 months ]
  2. maximal elevations in blood concentrations of CK-MB enzyme and troponin-T [ Time Frame: Post procedure ]
  3. wall motion index [ Time Frame: During hospitalisation: day 3-5 ]
  4. Minimal lumen diameter [ Time Frame: 8 months ]
  5. frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment. [ Time Frame: 8 months ]
  6. Occurrence of stent thrombosis and MACE. [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192868


Locations
Denmark
Cardiac Cath Lab, Rigshospitalet
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Denmark
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00192868     History of Changes
Other Study ID Numbers: DEDICATION
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009

Keywords provided by Rigshospitalet, Denmark:
primary PCI
distal protection
drug eluting stent
restenosis

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases