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| Name | Class |
|---|---|
| Wuhan Asia Heart Hospital | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
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The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The main question it aims to answer is :
• If standby cannulated ECMO as compared with prophylactic ECMO will improve the outcomes in patients undergoing high-risk PCI
Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention (PCI) with hemodynamic support may be feasible for these high-risk patients. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can be used to provide hemodynamic support during high-risk PCI procedures. However, ECMO might increase the rates of severe complications, such as bleeding and limb ischemia. Additionally, some patients might not need the support of ECMO. In this context, investigators propose a standby cannulated ECMO strategy, in which femoral cannulas are inserted and connected to primed circuit, and ECMO is initiated when needed. Therefore, investigators will conduct a prospective randomized clinical trial to compare outcomes between standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk PCI. Investigators will randomly assign 176 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease or severely depressed left ventricular function to standby cannulated ECMO group (n=88) or prophylactic ECMO (n=88). The primary end point was the 30-day incidence of major adverse events, including all-cause death, myocardial infraction, any repeat revascularization procedure, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standby cannulated ECMO | Experimental | For standby cannulated ECMO procedures, femoral cannulas are inserted either by percutaneous approach or surgical approach. The primed circuit is connected to the inserted ECMO cannulas, clamps are kept on circuit, and ECMO is on standby during PCI. When PCI cause hemodynamic instability, clamps on circuit are removed, and VA-ECMO is initiated to maintain maintain adequate systemic pressure and perfusion. |
|
| Prophylactic ECMO | Active Comparator | Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI. Femoral cannulas are inserted either by percutaneous approach or surgical approach. Following cannula placement, VA-ECMO is initiated to maintain adequate systemic pressure and perfusion during PCI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standby cannulated ECMO | Procedure | Femoral cannulas are inserted and connected to the primed circuit. Clamps are kept on circuit, and ECMO is on standby during PCI. ECMO is initiated if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite rate of 9 major adverse events | included all-cause death, myocardial infraction, repeat revascularization, stroke, percutaneous coronary intervention failure, limb ischemia, major bleeding, vascular injury requiring intervention, and need for renal replacement therapy | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedural hemoglobin decline | The relative decrease in hemoglobin from the pre-procedural value to the nadir post-procedural value | 30 days |
| Post-procedural platelet count decline | The relative decrease in platelet count from the pre-procedural value to the nadir post-procedural value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Hou, MD | Contact | 010-64456631 | xt.hou@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaotong Hou, MD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| People's Hospital of Guangxi Zhuang Autonomous Region |
| OTHER |
| The First Affiliated Hospital of Lanzhou Medical University | UNKNOWN |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
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| Prophylactic ECMO | Procedure | Prophylactic ECMO procedures are performed in the catheterization laboratory before PCI. |
|
| 30 days |
| RBC transfusion rate | The percentage of patients who receive at least one unit of packed red blood cells | 30 days |
| Serum interleukin-6 concentration | Highest level of IL-6 during concentration | 30 days |
| Duration of ECMO support | Time on ECMO support | 30 days |
| Length of hospital stay | Time of hospitalization | 30 days |
| Hospitalization cost | The total cost until the discharge from the hospital | 30 days |
| Use of intra-aortic balloon pump (IABP) | Unplanned initiation of IABP after randomization | 30 days |
| Each component of the composite major adverse events | The incidence of all-cause death, myocardial infraction, repeat revascularization, stroke, PCI failure, limb ischemia, major bleeding, vascular injury requiring intervention, or need for RRT | 30 days |