Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

Running, not enrolling

Conditions studied: Cardiogenic Shock, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI, NSTEMI, Acute Myocardial Infarction of Right Ventricle (Disorder), Acute Myocardial Infarction of Left Ventricle, Acute Myocardial Infarction With ST Elevation

In brief

The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.

Key facts

Study ID

NCT05800951

Run by

Henry Ford Health System

People needed

124

Starts

2022-07-22

Expected to finish

2026-12-31

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI).
• Cardiogenic Shock present as defined by the presence of 2 OR MORE of the following criteria prior to PCI:
• Hypotension: systolic blood pressure ≤ 90mmHg at baseline (prior to PCI) or the use of inotropes or vasopressors to maintain SBP ≥ 90mmHg
• Evidence of end organ hypoperfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria
• Hemodynamic criteria: Cardiac Index of < 2.2 L/min/m2 or a cardiac power output (CPO) of ≤ 0.6 watts
• Patient underwent PCI within 12 hours of hospital presentation.
• Exclusion Registry Exclusion Criteria:
• AMICS patients who meet any of the following study exclusion criteria will have a limited set of data collected via a single-page Patient Exclusion Form completed and submitted within 45 days of hospital discharge, which includes the reason for exclusion, date of index PCI, and assessment of patient survival to hospital discharge:
• Evidence of Anoxic Brain Injury
• Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
• IABP placed prior to MCS
• Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
• Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
• Active bleeding for which MCS is contraindicated
• Recent major surgery for which MCS is contraindicated
• Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
• Known left ventricular thrombus for which MCS is contraindicated
• Mechanical aortic prosthetic valve
• Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Providence St. Joseph Hospital Orange — Orange, California, United States
• St. Anthony Hospital — Lakewood, Colorado, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• Northside Hospital Atlanta — Atlanta, Georgia, United States
• St. Elizabeth Edgewood Hospital — Edgewood, Kentucky, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Ascenion St. John Hospital — Detroit, Michigan, United States
• Spectrum Health Hospitals Fred and Lena Meijer Heart Center — Grand Rapids, Michigan, United States
• Hackensack Meridian Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
• Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States
• TriStar Centennial Medical Center — Nashville, Tennessee, United States
• Parkwest Medical Center — Nashville, Tennessee, United States
• Methodist Hospital — San Antonio, Texas, United States
• UVA University Hospital — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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