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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DP-TA | Experimental | distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) |
|
| c-PCI | Placebo Comparator | conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)) | Device | The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration |
| Measure | Description | Time Frame |
|---|---|---|
| Postinfarct Remodeling | postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reperfusion Success | microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR | 3-5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-ju Choi, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Natioinal University Bundang Hospital | Seongnam | South Korea |
Among them, 126 patients were randomized to receive either PCI with distal protection (n=65) or PCI alone (n=61). Fifty five patients per each group received post-PCI CMR. Forty one patients underwent 6 month MRI in distal protection group and 43 patients, in conventional PCI group.
Between Jan 24, 2004, and June 16, 2008, 550 patients with STEMI were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | DP-TA | distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) |
| FG001 | c-PCI | conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DP-TA | distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) |
| BG001 | c-PCI | conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postinfarct Remodeling | postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI | Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group. | Posted | Number | Number of participants with remodeling | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DP-TA | distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chang-Hwan Yoon | Seoul national university Bundang hospital | +82-31-787-7052 | changhwanyoon@snubh.org |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| c-PCI | Procedure | conventional PCI without Guard wire |
|
|
| MRI refusal |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Reperfusion Success | microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR | Not Posted | 3-5 days |
| 7 |
| 65 |
| 0 |
| 65 |
| EG001 | c-PCI | conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction | 7 | 61 | 0 | 61 |
| revascularization | Cardiac disorders | SNOMED CT | Systematic Assessment |
|
| stroke | Cardiac disorders | SNOMED CT | Systematic Assessment |
|
| admission due to heart failure | Cardiac disorders | SNOMED CT | Systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |