Back to resultsDistal Protection Device in ST-elevation Myocardial Infarction (STEMI)
Primary Purpose
ST-segment Elevation Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))
c-PCI
Sponsored by
About this trial
This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction focused on measuring ST-elevation myocardial infarction, percutaneous coronary intervention, cardiac magnetic resonance imaging, microvascular occlusion, myocardial salvage
Eligibility 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.
Sites / Locations
- Seoul Natioinal University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DP-TA
c-PCI
Arm Description
distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
Outcomes
Primary Outcome Measures
Postinfarct Remodeling
postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI
Secondary Outcome Measures
Reperfusion Success
microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR
Full Information
NCT ID
NCT01384019
First Posted
June 27, 2011
Last Updated
February 14, 2013
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01384019
Brief Title
Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
Official Title
Distal Protection Device Did Not Improve Microvascular Obstruction Evaluated by Cardiac MR After Primary Percutaneous Intervention for ST-elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction
Keywords
ST-elevation myocardial infarction, percutaneous coronary intervention, cardiac magnetic resonance imaging, microvascular occlusion, myocardial salvage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DP-TA
Arm Type
Experimental
Arm Description
distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
Arm Title
c-PCI
Arm Type
Placebo Comparator
Arm Description
conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
Intervention Type
Device
Intervention Name(s)
distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))
Other Intervention Name(s)
The GuardWire Plus (Medtronic Inc.)
Intervention Description
The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration
Intervention Type
Procedure
Intervention Name(s)
c-PCI
Other Intervention Name(s)
convenional PCI
Intervention Description
conventional PCI without Guard wire
Primary Outcome Measure Information:
Title
Postinfarct Remodeling
Description
postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reperfusion Success
Description
microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR
Time Frame
3-5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-ju Choi, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Natioinal University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
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