Comparing standby and prophylactic ECMO during high-risk heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Early intra-aortic balloon pump (IABP) use after venoarterial ECMO for cardiogenic shock

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.