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NCT05800951Active, not recruiting

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS Study)

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
124 (actual)
First submitted
5 Dec 2022
Start date
Jul 2022
Primary completion date
Dec 2026
Lead sponsor
Henry Ford Health System
NCT number
NCT05800951

What you commit to

  • Study type: Observational
  • Participants enrolled: 124
  • From Jul 2022 to the primary completion date, Dec 2026
  • 17 sites 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lehigh Valley Hospital-Cedar Crest
Coordinator of this site? Confirm its status
AllentownUnited StatesUnknown status
Northside Hospital Atlanta
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AtlantaUnited StatesUnknown status
UVA University Hospital
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CharlottesvilleUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Ascenion St. John Hospital
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DetroitUnited StatesUnknown status
St. Elizabeth Edgewood Hospital
Coordinator of this site? Confirm its status
EdgewoodUnited StatesUnknown status
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesUnknown status
Fort Sanders Regional Medical Center
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
St. Anthony Hospital
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LakewoodUnited StatesUnknown status
Loma Linda University Medical Center
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Loma LindaUnited StatesUnknown status
Ronald Reagan UCLA Medical Center
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Los AngelesUnited StatesUnknown status
TriStar Centennial Medical center
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NashvilleUnited StatesUnknown status
Parkwest Medical Center
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NashvilleUnited StatesUnknown status
Hackensack Meridian Jersey Shore University Medical Center
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Neptune CityUnited StatesUnknown status
Providence St. Joseph Hospital Orange
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OrangeUnited StatesUnknown status
Methodist Hospital
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
George Washington University Hospital
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.