PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock.
Holger Thiele, Ibrahim Akin, Marcus Sandri...
https://pubmed.ncbi.nlm.nih.gov/29083953Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04184635
Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-14
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether early use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) combined with an intra-aortic balloon pump (IABP) can improve outcomes in patients experiencing cardiogenic shock due to acute myocardial infarction (AMI). This trial compares this combined approach to optimal medical treatment alone. Cardiogenic shock after AMI has a high mortality rate, often exceeding 40%, and VA-ECMO with IABP is being studied as a way to reduce this risk. Participants will be randomly assigned to one of two groups. The experimental group receives VA-ECMO support started as soon as possible, with IABP inserted in the opposite femoral artery, and management following a detailed protocol. For patients at centers without ECMO capability, a mobile ECMO team will initiate ECMO and transfer the patient to an ECMO center. The control group will receive standard medical care for cardiogenic shock according to current guidelines, without IABP or other temporary circulatory support devices, except for rescue VA-ECMO under specific severe conditions. During the study, participants will be monitored closely with assessments including survival, organ function, adverse cardiovascular events, bleeding, and heart function at 30 days and one year. The primary outcome is treatment failure at day 30. Researchers will also examine complications related to ECMO and quality of life measures. Consent is obtained from a relative or the patient when possible, and emergency consent procedures apply when needed. The study aims to provide evidence on whether early VA-ECMO plus IABP improves survival and organ support in this critical condition.
CONDITIONS
Brief Title
Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI)
- Planned or completed revascularization by PCI within 60 minutes for acute myocardial infarction
- Systolic blood pressure below 90 mmHg for more than 30 minutes or requiring medication to maintain it above 90 mmHg
- Signs of pulmonary congestion
- Signs of impaired organ perfusion including altered mental status, cold or clammy skin, urine output less than 30 ml/h, or serum lactate over 2.0 mmol/l
You will not qualify if you...
- Age under 18 years
- Pregnancy
- Onset of shock more than 24 hours prior
- Shock caused by hypovolemia, anaphylaxis, vagal reaction, or massive pulmonary embolism
- Resuscitation lasting more than 30 minutes
- No heart activity
- Patient moribund or with SAPS II score over 90 at randomization
- Planned or prior surgical revascularization (CABG) before randomization
- Fixed dilated pupils or irreversible brain injury
- Mechanical complications of infarction requiring surgery
- Severe peripheral artery disease or previous major artery surgery preventing ECMO or IABP insertion
- Aortic regurgitation greater than grade II
- Other severe diseases limiting life expectancy to less than one year
- Proven heparin-induced thrombocytopenia
- ECMO device not immediately available
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 24 hours before randomization
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to randomization
Treatment
Duration - Duration of VA-ECMO support and medical treatment as clinically indicated
Participants receive either early VA-ECMO combined with IABP and optimal medical treatment or optimal medical treatment alone for cardiogenic shock due to acute myocardial infarction.
Treatment begins immediately after randomization; mobile ECMO team initiates ECMO if randomized to ECMO arm
Follow-up
Duration - Up to 1 year after treatment
Participants are monitored for outcomes including treatment failure, mortality, and adverse events up to 1 year after treatment.
Visits at day 30 and one year for outcome assessments
Trial Site Locations
Total: 1 location
1
Hôpital Pitié Salpétrière
Paris, France, 75013
Actively Recruiting
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Research Team
A
Alain COMBES, MD, PhD
G
Gilles MONTALESCOT, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).
Authors/Task Force members, Stephan Windecker, Philippe Kolh...
https://pubmed.ncbi.nlm.nih.gov/25173339One-Year Outcomes after PCI Strategies in Cardiogenic Shock.
Holger Thiele, Ibrahim Akin, Marcus Sandri...
https://pubmed.ncbi.nlm.nih.gov/30145971Outcome after revascularisation of acute myocardial infarction with cardiogenic shock on extracorporeal life support.
Pavel Overtchouk, Julien Pascal, Guillaume Lebreton...
https://pubmed.ncbi.nlm.nih.gov/29400656The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock.
Grégoire Muller, Erwan Flecher, Guillaume Lebreton...
https://pubmed.ncbi.nlm.nih.gov/26825953