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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192868
First received: September 12, 2005
Last updated: September 22, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
 Procedure: Distal protection and drug eluting stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • ST segment resolution [ Time Frame: 90 min ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restenosis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • maximal elevations in blood concentrations of CK-MB enzyme and troponin-T [ Time Frame: Post procedure ] [ Designated as safety issue: No ]
  • wall motion index [ Time Frame: During hospitalisation: day 3-5 ] [ Designated as safety issue: No ]
  • Minimal lumen diameter [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Occurrence of stent thrombosis and MACE. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: May 2005
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

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

ClinicalTrials.gov Identifier: NCT00192868     History of Changes
Other Study ID Numbers: DEDICATION
Study First Received: September 12, 2005
Last Updated: September 22, 2009
Health Authority: Denmark: National Board of Health

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

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

ClinicalTrials.gov processed this record on June 18, 2013