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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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
 Device: Coronary thrombus aspiration catheter
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Niguarda Hospital:

Primary Outcome Measures:
  • ST-segment resolution immediately after primary angioplasty
  • Myocardial Blush grade after angioplasty.

Secondary Outcome Measures:
  • Coronary TIMI flow grade,
  • distal embolization,
  • no reflow

Estimated Enrollment: 160
Study Start Date: March 2004
Estimated Study Completion Date: September 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257153

Locations
Italy
Cardiology department, Niguarda hospital
Milan, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
Investigators
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.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00257153     History of Changes
Other Study ID Numbers: DEAR-MI
Study First Received: November 18, 2005
Last Updated: December 1, 2006
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Niguarda Hospital:
Acute myocardial infarction
primary angioplasty
myocardial reperfusion
thrombus aspiration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013