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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Acute Myocardial Infarction

Keywords

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Acute myocardial infarction primary angioplasty myocardial reperfusion thrombus aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Coronary thrombus aspiration catheter

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Pedro L Silva-Orrego, MD

Role: PRINCIPAL_INVESTIGATOR

Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital

Riccardo Bigi, MD

Role: STUDY_CHAIR

Cardiology Dpt. of medicine and surgery, University school of medicine, Milan, Italy

Paola Colombo

Role: STUDY_DIRECTOR

Cardiology Dpt. Niguarda hospital

Silvio Klugmann, MD

Role: STUDY_CHAIR

cardiology Dpt. Niguarda hospital.

Locations

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Cardiology department, Niguarda hospital

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT

PMID: 17045887 (View on PubMed)

Other Identifiers

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DEAR-MI

Identifier Type: -

Identifier Source: org_study_id