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| Name | Class |
|---|---|
| Terumo Corporation | INDUSTRY |
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It is known that no reflow phenomenon by microvascular obstruction after revascularization in STEMI increase infarct size, cardiac remodeling, and a risk of late mortality. Major mechanism of microvascular obstruction is distal embolization during procedure. Some investigators showed deferred stenting decreased the degree of microvascular obstruction compared with immediate stenting in STEMI. The aim of current study is to compare impact of immediate stent implantation versus deferred stent implantation on infarct size and microvascular perfusion in patients with ST-segment elevation myocardial infarction (STEMI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate coronary stenting | Placebo Comparator | Within enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, stent implantation is done on the initial procedure in immediate coronary stenting group |
|
| Deferred coronary stenting | Active Comparator | Within enrolled patients who agreed to participate in the study, signed informed consent and being satisfied with inclusion and exclusion criteria, only TIMI Ⅲ flow achievement is done on the initial procedure and stent implantation is deferred after 5-7 days admission in the deferred coronary stenting group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferred coronary stenting | Procedure | Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size measured by cardiac magnetic resonance image (MRI) | Post MI 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular obstruction (MVO) volume measured by cardiac MRI | Post MI 30 days | |
| Ratio of MVO volume to infarct size | Post MI 30 days | |
| Enzymatic infarct size |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricle (LV) ejection fraction | Post MI 6 months | |
| Left ventricle (LV) remodelling index | Post MI 6 months | |
| MACCE (major adverse cardiac and cerebrovascular event) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheol Woong Yu, M.D.,Ph.D. | Cardiovascular center, Korea university Anam hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34260542 | Derived | Kook H, Lee HJ, Kim MN, Yu CW, Kim JS, Joo HJ, Park JH, Hong SJ, Kim TH, Jang HJ, Park JS, Choi RK, Choi YJ, Kim YM, Lim DS, Ro YM. Effects of deferred versus immediate stenting on left ventricular function in patients with ST elevation myocardial infarction. Medicine (Baltimore). 2021 Jul 16;100(28):e26598. doi: 10.1097/MD.0000000000026598. | |
| 27965296 |
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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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|
| Immediate coronary stenting | Procedure | Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure. |
|
| Post MI 30 days |
| Degree of resolution of ST-segment elevation | 1 hour after coronary stenting |
| CTFC (corrected TIMI frame count) | Immediately after coronary stenting |
| Myocardial brush grade | Immediately after coronary stenting |
| Rate of slow flow or no reflow phenomenon (TIMI flow≤2) | Immediately after coronary stenting |
| Post MI 1, 6, 12 month |
| Kim JS, Lee HJ, Woong Yu C, Kim YM, Hong SJ, Park JH, Choi RK, Choi YJ, Park JS, Kim TH, Jang HJ, Joo HJ, Cho SA, Ro YM, Lim DS. INNOVATION Study (Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST-Segment-Elevation Myocardial Infarction). Circ Cardiovasc Interv. 2016 Dec;9(12):e004101. doi: 10.1161/CIRCINTERVENTIONS.116.004101. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |