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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014