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

Phase 4

Completed

• Conditions: ST-segment Elevation Myocardial Infarction
• Interventions: Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)); Procedure: c-PCI

• Registration Number: NCT01384019
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2008-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Study Completion: 2011-08
• Results First Submitted: 2013-01-14
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-14
• Last Update Submitted: 2013-02-14
• Results First Posted: 2013-03-18
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• 30 and less than 80 years presenting with STEMI
• more than 30 minutes but less than 12 hours after symptom onset
• with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block
• for whom primary PCI was intended

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Exclusion Criteria

• included thrombolytic therapy before PCI;
• spontaneous restoration of coronary flow (> TIMI grade II or III);
• cardiogenic shock (Killip class IV);
• major surgery or active bleeding within 6 weeks;
• aspirin, thienopyridine, or heparin allergy;
• neutropenia (<1000 neutrophils/mm3), thrombocytopenia (<100000 platelets/mm3), hepatic dysfunction, or renal insufficiency (serum creatinine level >2.5 mg/dL [221 μmol/L]);
• noncardiac condition with expected survival less than 1 year;
• current participation in other investigations.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DP-TA	distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))	distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
c-PCI	c-PCI	conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction

Primary Outcome Measures

Name	Time	Method
Postinfarct Remodeling	6 months	postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI

Secondary Outcome Measures

Name	Time	Method
Reperfusion Success	3-5 days	microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR

Trial Locations

Locations (1)

Seoul Natioinal University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of