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

NCT00192868 | Unknown

• 1 other identifier: DEDICATION
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

primary PCI; distal protection; drug eluting stent; restenosis

Outcome Measures

Primary Outcomes (2)

• ST segment resolution

  90 min

• Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).

  immediately after and at 8 month follow up

Secondary Outcomes (6)

• Restenosis

  8 months

• maximal elevations in blood concentrations of CK-MB enzyme and troponin-T

  Post procedure

• wall motion index

  During hospitalisation: day 3-5

• Minimal lumen diameter

  8 months

• frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.

  8 months

Interventions

Distal protection and drug eluting stent PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Cardiac Cath Lab, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Related Publications (4)

• 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.

  PMID: 20688033 DERIVED

• 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.

  PMID: 20185036 DERIVED

• 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.

  PMID: 18725489 DERIVED

• 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.

  PMID: 18308157 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Henning Kelbaek, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2011
• Last Updated: September 23, 2009

Record last verified: 2009-09

Locations

DK (1)