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This study will compare clinical outcomes of immediate stent implantation with deferred stent implantation(4-10days after primary angiography) for patients presented with acute myocardial infarction due to left main coronary artery occlusion.
Primary percutaneous coronary intervention for patients presented with acute myocardial infarction caused by left main coronary artery occlusion is associated with significantly higher mortality and risks of major cardiac adverse events. Deferred stent implantation may improve prognosis of primary PCI through reducing distal embolization and no-reflow phenomenon. There is no randomized clinical trial focuses on the effect and outcome of deferred stent implantation on primary PCI for left main coronary artery occlusion in contrast with conventional strategy.
This prospective, multicenter, randomized trial is aimed to compare immediate stenting with deferred stenting for LM-AMI with 30 centers in China involved. We hope to determine whether deferred stenting is superior to conventional strategy for primary PCI of AMI caused by left main coronary artery occlusion in improving long-term clinical outcomes and cardiac function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferred stent implantation | Experimental | Drug-eluting stents are implanted 4-10 days after primary angiography and restoration of blood flow in left main coroanry artery in a secondary PCI |
|
| Immediate stent implantation | Active Comparator | Drug-eluting stents are implanted immediately after primary angiography and restoration of blood flow in left main coroanry artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferred stent implantation | Device | Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of cardiac death and recurrent myocardial infarction | Recorded in follow-up | 30 days after primary angiography |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death, cardiac death, recurrent myocardial infarction, target vessel revascularization | Recorded in follow-up | 30 days after primary angiography |
| Residual stenosis of left main coronary artery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Zhang, M.D. | Contact | 13917149007 | zhang.feng@zs-hospital.sh.cn | |
| Yang Gao, M.D. | Contact | 18801970322 | gysc20@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, M.D. | Zhongshan Hospital,Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30850023 | Derived | Gao Y, Zhang F, Li C, Dai Y, Yang J, Qu Y, Qian J, Ge J; OPTIMAL trial investigators. Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial. Trials. 2019 Mar 8;20(1):162. doi: 10.1186/s13063-019-3211-0. |
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| Immediate stent implantation | Device | Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI. |
|
Measured through angiography
| Immediately after stent implantation and 12 months after primary angiography |
| Left ventricular ejection fraction | Measured through echocardiogram | 30 days and 12 months after primary angiography |