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

ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384019
• Other study ID #: SNUBH-001
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2011
• Last updated: February 14, 2013
• Start date: January 2004
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2011
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul Natioinal University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postinfarct Remodeling	postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI	6 months	No
Secondary	Reperfusion Success	microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR	3-5 days	No