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
- Diseases
- Coronary artery disease
- 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
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lehigh Valley Hospital-Cedar Crest Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Northside Hospital Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| UVA University Hospital Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Ascenion St. John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| St. Elizabeth Edgewood Hospital Coordinator of this site? Confirm its status | Edgewood | United States | Unknown status |
| Spectrum Health Hospitals Fred and Lena Meijer Heart Center Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Fort Sanders Regional Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| St. Anthony Hospital Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Ronald Reagan UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| TriStar Centennial Medical center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Parkwest Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Hackensack Meridian Jersey Shore University Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Unknown status |
| Providence St. Joseph Hospital Orange Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Methodist Hospital Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| George Washington University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.