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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

September 12, 2005
September 22, 2009
May 2005
November 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Wall motion index at 8 months
  • Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
Complete list of historical versions of study NCT00192868 on ClinicalTrials.gov Archive Site
  • 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 ]
  • During hospitalisation:
  • ST-segment resolution
  • maximal elevations in blood concentrations of CK-MB enzyme and troponin-T
  • wall motion index at day 3-5.
  • 8 months:
  • Minimal lumen diameter,
  • frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.
  • 4 and 12 months:
  • Occurrence of stent thrombosis and MACE.
Not Provided
Not Provided
 
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
Procedure: Distal protection and drug eluting stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
November 2011
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00192868
DEDICATION
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP