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

Acute Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257153
• Other study ID #: DEAR-MI
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2005
• Last updated: December 1, 2006
• Start date: March 2004
• Est. completion date: September 2005

Study information

• Verified date: June 2005
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Coronary thrombus aspiration catheter

Locations

Country	Name	City	State
Italy	Cardiology department, Niguarda hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalò G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST-segment resolution immediately after primary angioplasty
Primary	Myocardial Blush grade after angioplasty.
Secondary	Coronary TIMI flow grade,
Secondary	distal embolization,
Secondary	no reflow