Clinical trial NCT06274411: Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
Official title: Standby Cannulated ECMO Versus Prophylactic ECMO in Patients Undergoing High-Risk Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ECMO
High-risk PCI
Keywords: ECMO
PCI
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Asia Heart Hospital
name: The First Hospital of Jilin University
name: First Affiliated Hospital of Harbin Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: The First Affiliated Hospital of Lanzhou Medical University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: First Hospital of China Medical University
First posted: 2024-02-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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, bleeding, surgical revision and renal replacement therapy.

Eligibility criteria: Inclusion Criteria:

1. Clinicians decide to perform PCI during ECMO support.
2. Age of ≥18
3. Patient presents with a compromised ejection fraction of less than 35% or at risk of hemodynamic deterioration, or intervention on the last patent coronary conduit or an unprotected left main artery, or complex 3-vessel disease (SYNTAX score of ≥33)
4. Informed consent

Exclusion Criteria:

1. Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP \>90mmHg)
2. Presence of moderate to severe aortic insufficiency
3. Severe peripheral vascular disease
4. creatinine≥4mg/dL
5. Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN
6. History of recent (within 1 month) stroke or TIA
7. Abnormal coagulation(defined as platelet count ≤50000/mm3 or Fibrinogen ≤1.50g/L)
8. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors, or documented heparin induced thrombocytopenia.

Primary outcomes:
measure: Composite rate of 9 major adverse events
timeFrame: 30 days
Secondary outcomes:
measure: Platelet drop
timeFrame: 30 days
measure: Hemoglobin drop
timeFrame: 30 days
measure: RBC transfusion rate
timeFrame: 30 days
measure: Serum interleukin-6 concentration
timeFrame: 30 days
measure: Duration of ECMO support
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Hospitalization cost
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Xiaotong Hou, MD
role: PRINCIPAL_INVESTIGATOR
References: