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

NCT ID: NCT01384019

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2011-08-31

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).

Conditions

ST-segment Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DP-TA

distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)

Group Type: EXPERIMENTAL

distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))

Intervention Type: DEVICE

The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration

c-PCI

conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction

Group Type: PLACEBO_COMPARATOR

c-PCI

Intervention Type: PROCEDURE

conventional PCI without Guard wire

Interventions

distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))

The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration

Intervention Type: DEVICE

c-PCI

conventional PCI without Guard wire

Intervention Type: PROCEDURE

Other Intervention Names

The GuardWire Plus (Medtronic Inc.); convenional PCI

Eligibility Criteria

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

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong-Ju Choi

director of cardiovascular center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-ju Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul Natioinal University Bundang Hospital

Seongnam, , South Korea

Countries

South Korea

Other Identifiers

SNUBH-001

Identifier Type: -

Identifier Source: org_study_id