Back to resultsThrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Coronary thrombus aspiration catheter
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, primary angioplasty, myocardial reperfusion, thrombus aspiration
Eligibility 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.
Sites / Locations
- Cardiology department, Niguarda hospital
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00257153
Brief Title
Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Niguarda Hospital
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, primary angioplasty, myocardial reperfusion, thrombus aspiration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Coronary thrombus aspiration catheter
Primary Outcome Measure Information:
Title
ST-segment resolution immediately after primary angioplasty
Title
Myocardial Blush grade after angioplasty.
Secondary Outcome Measure Information:
Title
Coronary TIMI flow grade,
Title
distal embolization,
Title
no reflow
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro L Silva-Orrego, MD
Organizational Affiliation
Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riccardo Bigi, MD
Organizational Affiliation
Cardiology Dpt. of medicine and surgery, University school of medicine, Milan, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paola Colombo
Organizational Affiliation
Cardiology Dpt. Niguarda hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Silvio Klugmann, MD
Organizational Affiliation
cardiology Dpt. Niguarda hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Cardiology department, Niguarda hospital
City
Milan
ZIP/Postal Code
20162
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17045887
Citation
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. doi: 10.1016/j.jacc.2006.03.068. Epub 2006 Sep 26.
Results Reference
result
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Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
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