NCT04184635Recruiting
Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock
Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)
Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Data from case series and large retrospective trials suggest that the early treatment of cardiogenic shock AMI patients with the association of VA-ECMO and IABP may significantly decrease mortality, which is still unacceptably high nowadays (40-50% at 30 days). An important benefit for the patients randomized to the ECMO arm is expected and the risk-to-benefit ratio is expected to be in favor of the experimental treatment arm.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 28 Nov 2019
- Start date
- 14 Oct 2021
- Primary completion date
- 14 Oct 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT04184635
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 14 Oct 2021 to the primary completion date, 14 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical revascularization for AMI (CABG) planned or already performed prior to randomization
- Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding ECMO and IABP insertion
- Other severe concomitant disease with limited life expectancy \< 1 year
Other illness
- No intrinsic heart activity
Age
- Age \<18 years
Other
- Pregnancy
- Onset of shock \>24 Hours
- Shock of other cause (hypovolemic, anaphylactic or vagal shock)
- Shock due to massive pulmonary embolism
- Resuscitation \>30 minutes
- Patient moribund on the day of randomization or SAPS II \>90
- Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology
- Mechanical infarction complication (massive mitral regurgitation, pericardium drainage required, septal ventricular defect)
- Aortic regurgitation \> II
- Proven heparin-induced thrombocytopenia
- ECMO device not immediately available
Who the study is looking for
- Cardiogenic shock complicating acute myocardial infarction (STEMI or NSTEMI)
- Revascularization by PCI for acute myocardial infarction has been performed or is planned in the following 60 minutes
- Systolic blood pressure \<90 mmHg for \>30 min or catecholamine support required to maintain systolic blood pressure \>90 mmHg
- Signs of pulmonary congestion
- Signs of impaired organ perfusion with at least one of the following:
- Altered mental status OR cold, clammy skin and extremities OR oliguria with urine output \<30 ml/h OR serum lactate \>2.0 mmol/l
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.