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OpenTrials
Completed

NCT Number: NCT00257153

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

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology department, Niguarda hospital

Milan, 20162, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary thrombus aspiration catheter

Device

Primary outcomes

  1. ST-segment resolution immediately after primary angioplasty

  2. Myocardial Blush grade after angioplasty.

Secondary outcomes

  1. Coronary TIMI flow grade,

  2. distal embolization,

  3. no reflow

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Nov 22, 2005
Registry last updated
Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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