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
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 April 17, 2014