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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384019
First Posted: June 28, 2011
Last Update Posted: March 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Dong-Ju Choi, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Postinfarct Remodeling [ Time Frame: 6 months ]
    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 ]
    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

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 27, 2011
First Posted: June 28, 2011
Results First Submitted: January 14, 2013
Results First Posted: March 18, 2013
Last Update Posted: March 18, 2013
Last Verified: February 2013

Keywords provided by Dong-Ju Choi, 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
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases