Back to resultsDrug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Distal protection and drug eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring primary PCI, distal protection, drug eluting stent, restenosis
Eligibility 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
Sites / Locations
- Cardiac Cath Lab, Rigshospitalet
Outcomes
Primary Outcome Measures
ST segment resolution
Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
Secondary Outcome Measures
Restenosis
maximal elevations in blood concentrations of CK-MB enzyme and troponin-T
wall motion index
Minimal lumen diameter
frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.
Occurrence of stent thrombosis and MACE.
Full Information
NCT ID
NCT00192868
First Posted
September 12, 2005
Last Updated
September 22, 2009
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00192868
Brief Title
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
Official Title
Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
primary PCI, distal protection, drug eluting stent, restenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Distal protection and drug eluting stent
Primary Outcome Measure Information:
Title
ST segment resolution
Time Frame
90 min
Title
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 Measure Information:
Title
Restenosis
Time Frame
8 months
Title
maximal elevations in blood concentrations of CK-MB enzyme and troponin-T
Time Frame
Post procedure
Title
wall motion index
Time Frame
During hospitalisation: day 3-5
Title
Minimal lumen diameter
Time Frame
8 months
Title
frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.
Time Frame
8 months
Title
Occurrence of stent thrombosis and MACE.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Kelbaek, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac Cath Lab, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20688033
Citation
Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Klovgaard L, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Helqvist S. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial. J Am Coll Cardiol. 2010 Aug 17;56(8):641-5. doi: 10.1016/j.jacc.2010.05.009.
Results Reference
derived
PubMed Identifier
20185036
Citation
Kaltoft A, Kelbaek H, Klovgaard L, Terkelsen CJ, Clemmensen P, Helqvist S, Lassen JF, Thuesen L. Increased rate of stent thrombosis and target lesion revascularization after filter protection in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: 15-month follow-up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2010 Mar 2;55(9):867-71. doi: 10.1016/j.jacc.2009.09.052.
Results Reference
derived
PubMed Identifier
18725489
Citation
Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klovgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Lassen JF; DEDICATION Investigators. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial. Circulation. 2008 Sep 9;118(11):1155-62. doi: 10.1161/CIRCULATIONAHA.107.758698. Epub 2008 Aug 25.
Results Reference
derived
PubMed Identifier
18308157
Citation
Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
Results Reference
derived
Learn more about this trial
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
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