Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
This study has been completed.
Sponsor:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01384019
First received: June 27, 2011
Last updated: February 14, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
ST-segment Elevation Myocardial Infarction |
Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)) Procedure: c-PCI |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by Seoul National University Bundang Hospital:
Primary Outcome Measures:
- Postinfarct Remodeling [ Time Frame: 6 months ] [ Designated as safety issue: No ]postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI
Secondary Outcome Measures:
- Reperfusion Success [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR
| Enrollment: | 126 |
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DP-TA
distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
|
Device: distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))
The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration
Other Name: The GuardWire Plus (Medtronic Inc.)
|
|
Placebo Comparator: c-PCI
conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
|
Procedure: c-PCI
conventional PCI without Guard wire
Other Name: convenional PCI
|
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).
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384019
Locations
| Korea, Republic of | |
| Seoul Natioinal University Bundang Hospital | |
| Seongnam, Korea, Republic of | |
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
| Principal Investigator: | Dong-ju Choi, MD | Seoul National University Bundang Hospital |
More Information
No publications provided
| Responsible Party: | Dong-Ju Choi, director of cardiovascular center, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT01384019 History of Changes |
| Other Study ID Numbers: | SNUBH-001 |
| Study First Received: | June 27, 2011 |
| Results First Received: | January 14, 2013 |
| Last Updated: | February 14, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Bundang Hospital:
|
ST-elevation myocardial infarction percutaneous coronary intervention cardiac magnetic resonance imaging microvascular occlusion myocardial salvage |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013