Comparing standby and prophylactic ECMO during high-risk heart procedures
Standby Cannulated ECMO Versus Prophylactic ECMO In Patients Undergoing High-Risk Percutaneous Coronary Intervention
This study is testing whether using standby ECMO instead of routine ECMO can help patients with serious heart issues have better outcomes during high-risk heart procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Anzhen Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06274411 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized trial aims to evaluate the effectiveness of standby cannulated ECMO compared to prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI). The study will enroll 176 symptomatic patients with complex coronary artery disease and will randomly assign them to either the standby or prophylactic ECMO group. The primary endpoint is the incidence of major adverse events within 30 days post-procedure, including death, myocardial infarction, and other serious complications. The goal is to determine if standby ECMO can improve patient outcomes while minimizing unnecessary risks associated with prophylactic ECMO.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe coronary artery disease and compromised heart function who are undergoing PCI.
Not a fit: Patients in cardiogenic shock or with severe comorbidities such as significant aortic insufficiency or severe peripheral vascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better outcomes and reduced complications for patients undergoing high-risk PCI.
How similar studies have performed: While the use of ECMO in high-risk PCI is established, the specific comparison of standby versus prophylactic ECMO is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiaotong Hou, MD — Beijing Anzhen Hospital
- Study coordinator: Xiaotong Hou, MD
- Email: xt.hou@ccmu.edu.cn
- Phone: 010-64456631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.