We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 22, 2005
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Niguarda Hospital
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257153

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

ClinicalTrials.gov Identifier: NCT00257153     History of Changes
Other Study ID Numbers: DEAR-MI
First Submitted: November 18, 2005
First Posted: November 22, 2005
Last Update Posted: December 4, 2006
Last Verified: June 2005

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

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