Clinical trial NCT00192868: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: primary PCI
distal protection
drug eluting stent
restenosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ST segment resolution
timeFrame: 90 min
measure: Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
timeFrame: immediately after and at 8 month follow up
Secondary outcomes:
measure: Restenosis
timeFrame: 8 months
measure: maximal elevations in blood concentrations of CK-MB enzyme and troponin-T
timeFrame: Post procedure
measure: wall motion index
timeFrame: During hospitalisation: day 3-5
measure: Minimal lumen diameter
timeFrame: 8 months
measure: frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.
timeFrame: 8 months
measure: Occurrence of stent thrombosis and MACE.
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Cardiac Cath Lab, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henning Kelbaek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.