Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinicians decide to perform PCI during ECMO support.
Age of ≥18
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)
Informed consent
Disqualifiers
Subject in cardiogenic shock(need inotrope, pressor or mechanical support to maintain SBP >90mmHg)
Presence of moderate to severe aortic insufficiency
Severe peripheral vascular disease
creatinine≥4mg/dL
Trial design
Design model
Parallel
Treatments tested in this trial
Standby cannulated ECMO
Procedure/SurgeryFemoral 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.
Prophylactic ECMO
Procedure/SurgeryProphylactic ECMO procedures are performed in the catheterization laboratory before PCI.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Standby cannulated ECMOExperimental treatment 1 intervention
Group B: Prophylactic ECMOActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
30 daysSecondary outcomes
1
Post-procedural hemoglobin decline
The relative decrease in hemoglobin from the pre-procedural value to the nadir post-procedural value
Time frame
30 days2
Post-procedural platelet count decline
The relative decrease in platelet count from the pre-procedural value to the nadir post-procedural value
Time frame
30 days3
RBC transfusion rate
The percentage of patients who receive at least one unit of packed red blood cells
Time frame
30 days4
Serum interleukin-6 concentration
Highest level of IL-6 during concentration
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Anzhen Hospital
Lead sponsor
Wuhan Asia Heart Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
People's Hospital of Xinjiang Uygur Autonomous Region
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
The First Affiliated Hospital of Lanzhou Medical University
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Source ClinicalTrials.gov