NCT01384019

Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)

Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.

Detailed description

Patients with first-diagnosed STEMI were randomly assigned to distal protection and thrombus aspiration (DP-TA) pretreatment during percutaneous coronary intervention (PCI) or conventional PCI (c-PCI). The primary endpoint was the remodeling index (RI), measured by cardiac magnetic resonance imaging (CMR) post-PCI and 6 months after PCI. Secondary endpoints, determined by CMR within 3 to 5 days after PCI, included the infarct ratio (infarct size to entire left ventricular \[LV\] size ) by delayed-enhancement (DE), area at risk (AAR) ratio (AAR to LV size) by T2 high-signal intensity , microvascular occlusion index (MVO) ratio (MVO to LV size) by DE, and myocardial salvage index (MSI, \[AAR-infarct size\] x 100/AAR).

Conditions

• ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))	The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration
PROCEDURE	c-PCI	conventional PCI without Guard wire

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-06-01
• Completion: 2011-08-01
• First posted: 2011-06-28
• Last updated: 2013-03-18
• Results posted: 2013-03-18

Locations

1 site across 1 country: South Korea