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Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.

This study has been completed.
Sponsor:
Information provided by:
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT00257153
First received: November 18, 2005
Last updated: December 1, 2006
Last verified: June 2005
History of Changes

November 18, 2005
December 1, 2006
March 2004
 
  • ST-segment resolution immediately after primary angioplasty
  • Myocardial Blush grade after angioplasty.
Same as current
Complete list of historical versions of study NCT00257153 on ClinicalTrials.gov Archive Site
  • Coronary TIMI flow grade,
  • distal embolization,
  • no reflow
Same as current
 
 
 
Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
 

In patients with acute ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) may cause thrombus dislodgment and impaired microcirculatory reperfusion. This study was designed to test the hypothesis that thrombus aspiration before standard PCI may improve acute myocardial reperfusion, measured by ST-segment resolution (STR) and myocardial blush grade (MBG), compared with standard PCI.

Consecutive STEMI patients, admitted within 12 hours of symptom onset and scheduled for primary PCI are randomly assigned to two treatment strategies: standard PCI including stenting and abciximab (group1) or thrombus aspiration with Pronto™ extraction catheter (Vasc.solutions, Minneapolis) before standard PCI (group2). Patients with cardiogenic shock, previous infarction or thrombolytic therapy are excluded.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
Device: Coronary thrombus aspiration catheter
 
Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalo G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. Epub 2006 Sep 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
September 2005
 

Inclusion Criteria:

  • ST-segment elevation myocardial infarction patients undergoing primary angioplasty within 12 hours from symptom onset.

Exclusion Criteria:

  • Cardiogenic shock, previous infarction, previous coronary bypass surgery,bundle branch block or pacemaker induced rythm, controindications to IIb/IIIa inhibitors.
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00257153
DEAR-MI
 
 
Niguarda Hospital
 
Principal Investigator: Pedro L Silva-Orrego, MD Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital
Study Chair: Riccardo Bigi, MD Cardiology Dpt. of medicine and surgery, University school of medicine, Milan, Italy
Study Director: Paola Colombo Cardiology Dpt. Niguarda hospital
Study Chair: Silvio Klugmann, MD cardiology Dpt. Niguarda hospital.
Niguarda Hospital
June 2005

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