NCT00257153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
Last Updated

December 4, 2006

Status Verified

June 1, 2005

First QC Date

November 18, 2005

Last Update Submit

December 1, 2006

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionprimary angioplastymyocardial reperfusionthrombus aspiration

Outcome Measures

Primary Outcomes (2)

  • ST-segment resolution immediately after primary angioplasty

  • Myocardial Blush grade after angioplasty.

Secondary Outcomes (3)

  • Coronary TIMI flow grade,

  • distal embolization,

  • no reflow

Interventions

Coronary thrombus aspiration catheterDEVICE

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cardiogenic shock, previous infarction, previous coronary bypass surgery,bundle branch block or pacemaker induced rythm, controindications to IIb/IIIa inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology department, Niguarda hospital

Milan, 20162, Italy

Location

Related Publications (1)

  • 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.

    PMID: 17045887RESULT

Study Officials

  • Pedro L Silva-Orrego, MD

    Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital

    PRINCIPAL INVESTIGATOR

  • Riccardo Bigi, MD

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

    STUDY CHAIR

  • Paola Colombo

    Cardiology Dpt. Niguarda hospital

    STUDY DIRECTOR

  • Silvio Klugmann, MD

    cardiology Dpt. Niguarda hospital.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2005

First Posted

November 22, 2005

Study Start

March 1, 2004

Study Completion

September 1, 2005

Last Updated

December 4, 2006

Record last verified: 2005-06

Locations

IT(1)