Cardiogenic ShockCERAMICSNCT05800951
Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock
An observational study of Cardiogenic Shock and Acute Myocardial Infarction, run by Henry Ford Health System at 17 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction
- How many people
- 124 participants
- Where
- 17 sitesUnited States
- Study dates
- 22 Jul 2022to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present with an acute myocardial infarction (AMI) with cardiogenic shock (AMICS) prior to PCI.
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 12Show fewer
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Northside Hospital Atlanta
Atlanta, Georgia, 30342
UVA University Hospital
Charlottesville, Virginia, 22903
Henry Ford Hospital
Detroit, Michigan, 48202
Ascenion St. John Hospital
Detroit, Michigan, 48236
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, 41017
Spectrum Health Hospitals Fred and Lena Meijer Heart Center
Grand Rapids, Michigan, 49503
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
St. Anthony Hospital
Lakewood, Colorado, 80228
Loma Linda University Medical Center
Loma Linda, California, 92354
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Parkwest Medical Center
Nashville, Tennessee, 37923
Hackensack Meridian Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Providence St. Joseph Hospital Orange
Orange, California, 92868
Methodist Hospital
San Antonio, Texas, 78229
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS Study)
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.
Read the detailed description
The National Cardiogenic Shock Initiative (NCSI) was an initial step in helping to provide team based protocolized care in AMICS. Over the past 5 years, further evaluation and research has helped identify additional best practices that may contribute to further improving outcomes.
Vasopressors have been identified as being independently associated with worse outcomes and MCS escalation may lead to improvement. While sites participating in the NCSI were early adopters of MCS in AMICS, MCS escalation was open ended and dictated by variable local practice patterns. This contributed to the overall low rate of MCS escalation which occurred in NCSI.
Approximately 30-40% of patients with AMICS have concomitant right ventricular failure (RVF), which is associated with worse morality and may therefore benefit from consideration of early right ventricular mechanical circulatory support (RV-MCS) devices.
A total of 20 total sites will be accepted into the CERAMICS study with the goal of gathering data and outcomes of 120 patients treated at participating centers. The study is expected to collect data for approximately 2 years. Prior to joining the study, each site must have broad adoption of the NCSI treatment algorithm as the standard of care for AMICS among at least 80% of the interventional cardiologists who take STEMI call, as confirmed by the site principal investigator (PI).
It is critically important to track consecutive AMICS patients at each site to assess outcomes by identifying the total sample size treated and to help identify if there were particular biases regarding the use of MCS or escalation of MCS. We will also track survival to hospital discharge of those AMICS patients not treated with MCS via an exclusion form, as well as with patients treated with MCS including when care deviates from the study protocol.
All study data collection is occurring retrospectively at each time-point only using EMR, and there will be no contact between study personnel and patients. Patients will be discharged or deceased at the time of study entry. During participation in the study, study sites will regularly screen all acute MI patient records (STEMI and NSTEMI) for patients who presented with cardiogenic shock (AMICS) via a screening form.
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI, NSTEMI
- Medical subject headings
- Shock, Cardiogenic, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital discharge survival/survival at 30 days
Hospital discharge survival/survival at 30 days
Measured: Hospital discharge survival/survival at 30 days
Secondary outcomes (1)
All-cause mortality at 1 year
All-cause mortality at 1 year
Measured: All-cause mortality at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start22 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Principal investigator, Mir Babar Basir, Henry Ford Health System
- Investigators
- Mir B Basir, DO, Principal investigator, Henry Ford HealthWilliam W O'Neill, MD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800951
- Sponsor's protocol ID
- CERAMICS
- Acronym
- CERAMICS
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basir MB, Schreiber T, Dixon S, Alaswad K, Patel K, Almany S, Khandelwal A, Hanson I, George A, Ashbrook M, Blank N, Abdelsalam M, Sareen N, Timmis SBH, O'Neill Md WW. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative. Catheter Cardiovasc Interv. 2018 Feb 15;91(3):454-461. doi: 10.1002/ccd.27427. Epub 2017 Dec 20.
PubMed 29266676Hanson ID, Tagami T, Mando R, Kara Balla A, Dixon SR, Timmis S, Almany S, Naidu SS, Baran D, Lemor A, Gorgis S, O'Neill W, Basir MB; National Cardiogenic Shock Investigators. SCAI shock classification in acute myocardial infarction: Insights from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2020 Nov;96(6):1137-1142. doi: 10.1002/ccd.29139. Epub 2020 Jul 16.
PubMed 32672388Goldsweig AM, Tak HJ, Alraies MC, Park J, Smith C, Baker J, Lin L, Patel N, O'Neill WW, Basir MB; National Cardiogenic Shock Initiative Investigators. Mechanical Circulatory Support Following Out-of-Hospital Cardiac Arrest: Insights From the National Cardiogenic Shock Initiative. Cardiovasc Revasc Med. 2021 Nov;32:58-62. doi: 10.1016/j.carrev.2020.12.021. Epub 2020 Dec 23.
PubMed 33358390Lemor A, Basir MB, Gorgis S, Todd J, Marso S, Gelormini J, Akhtar Y, Baker J, Chahin J, Abdul-Waheed M, Thukral N, O'Neill W. Impact of Age in Acute Myocardial Infarction Cardiogenic Shock: Insights From the National Cardiogenic Shock Initiative. Crit Pathw Cardiol. 2021 Sep 1;20(3):163-167. doi: 10.1097/HPC.0000000000000255.
PubMed 33606413Basir MB, Kapur NK, Patel K, Salam MA, Schreiber T, Kaki A, Hanson I, Almany S, Timmis S, Dixon S, Kolski B, Todd J, Senter S, Marso S, Lasorda D, Wilkins C, Lalonde T, Attallah A, Larkin T, Dupont A, Marshall J, Patel N, Overly T, Green M, Tehrani B, Truesdell AG, Sharma R, Akhtar Y, McRae T 3rd, O'Neill B, Finley J, Rahman A, Foster M, Askari R, Goldsweig A, Martin S, Bharadwaj A, Khuddus M, Caputo C, Korpas D, Cawich I, McAllister D, Blank N, Alraies MC, Fisher R, Khandelwal A, Alaswad K, Lemor A, Johnson T, Hacala M, O'Neill WW; National Cardiogenic Shock Initiative Investigators. Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1173-1183. doi: 10.1002/ccd.28307. Epub 2019 Apr 25.
PubMed 31025538Ahlers MJ, Srivastava PK, Basir MB, O'Neill WW, Hacala M, Ammar K, Khalil S, Hollowed J, Nsair A. Characteristics and outcomes of patients presenting with acute myocardial infarction and cardiogenic shock during COVID-19. Catheter Cardiovasc Interv. 2022 Oct;100(4):568-574. doi: 10.1002/ccd.30390. Epub 2022 Sep 7.
PubMed 36073018
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS Study)
- ClinicalTrials.gov ID
- NCT05800951
- Acronym / sponsor ID
- CERAMICS / CERAMICS
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, STEMI, NSTEMI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The National Cardiogenic Shock Initiative (NCSI) was an initial step in helping to provide team based protocolized care in AMICS. Over the past 5 years, further evaluation and research has helped identify additional best practices that may contribute to further improving outcomes.
Vasopressors have been identified as being independently associated with worse outcomes and MCS escalation may lead to improvement. While sites participating in the NCSI were early adopters of MCS in AMICS, MCS escalation was open ended and dictated by variable local practice patterns. This contributed to the overall low rate of MCS escalation which occurred in NCSI.
Approximately 30-40% of patients with AMICS have concomitant right ventricular failure (RVF), which is associated with worse morality and may therefore benefit from consideration of early right ventricular mechanical circulatory support (RV-MCS) devices.
A total of 20 total sites will be accepted into the CERAMICS study with the goal of gathering data and outcomes of 120 patients treated at participating centers. The study is expected to collect data for approximately 2 years. Prior to joining the study, each site must have broad adoption of the NCSI treatment algorithm as the standard of care for AMICS among at least 80% of the interventional cardiologists who take STEMI call, as confirmed by the site principal investigator (PI).
It is critically important to track consecutive AMICS patients at each site to assess outcomes by identifying the total sample size treated and to help identify if there were particular biases regarding the use of MCS or escalation of MCS. We will also track survival to hospital discharge of those AMICS patients not treated with MCS via an exclusion form, as well as with patients treated with MCS including when care deviates from the study protocol.
All study data collection is occurring retrospectively at each time-point only using EMR, and there will be no contact between study personnel and patients. Patients will be discharged or deceased at the time of study entry. During participation in the study, study sites will regularly screen all acute MI patient records (STEMI and NSTEMI) for patients who presented with cardiogenic shock (AMICS) via a screening form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present with an acute myocardial infarction (AMI) with cardiogenic shock (AMICS) prior to PCI.
Key inclusion criteria (6 listed)
- 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:
- Patient underwent PCI within 12 hours of hospital presentation.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital discharge survival/survival at 30 days
Time frame: Hospital discharge survival/survival at 30 days
Hospital discharge survival/survival at 30 days
1 secondary outcome
All-cause mortality at 1 year
Time frame: All-cause mortality at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 29266676Basir MB, Schreiber T, Dixon S, Alaswad K, Patel K, Almany S, Khandelwal A, Hanson I, George A, Ashbrook M, Blank N, Abdelsalam M, Sareen N, Timmis SBH, O'Neill Md WW. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: The Detroit cardiogenic shock initiative. Catheter Cardiovasc Interv. 2018 Feb 15;91(3):454-461. doi: 10.1002/ccd.27427. Epub 2017 Dec 20.
- Background: PubMed 32672388Hanson ID, Tagami T, Mando R, Kara Balla A, Dixon SR, Timmis S, Almany S, Naidu SS, Baran D, Lemor A, Gorgis S, O'Neill W, Basir MB; National Cardiogenic Shock Investigators. SCAI shock classification in acute myocardial infarction: Insights from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2020 Nov;96(6):1137-1142. doi: 10.1002/ccd.29139. Epub 2020 Jul 16.
- Background: PubMed 33358390Goldsweig AM, Tak HJ, Alraies MC, Park J, Smith C, Baker J, Lin L, Patel N, O'Neill WW, Basir MB; National Cardiogenic Shock Initiative Investigators. Mechanical Circulatory Support Following Out-of-Hospital Cardiac Arrest: Insights From the National Cardiogenic Shock Initiative. Cardiovasc Revasc Med. 2021 Nov;32:58-62. doi: 10.1016/j.carrev.2020.12.021. Epub 2020 Dec 23.
- Background: PubMed 33606413Lemor A, Basir MB, Gorgis S, Todd J, Marso S, Gelormini J, Akhtar Y, Baker J, Chahin J, Abdul-Waheed M, Thukral N, O'Neill W. Impact of Age in Acute Myocardial Infarction Cardiogenic Shock: Insights From the National Cardiogenic Shock Initiative. Crit Pathw Cardiol. 2021 Sep 1;20(3):163-167. doi: 10.1097/HPC.0000000000000255.
- Background: PubMed 31025538Basir MB, Kapur NK, Patel K, Salam MA, Schreiber T, Kaki A, Hanson I, Almany S, Timmis S, Dixon S, Kolski B, Todd J, Senter S, Marso S, Lasorda D, Wilkins C, Lalonde T, Attallah A, Larkin T, Dupont A, Marshall J, Patel N, Overly T, Green M, Tehrani B, Truesdell AG, Sharma R, Akhtar Y, McRae T 3rd, O'Neill B, Finley J, Rahman A, Foster M, Askari R, Goldsweig A, Martin S, Bharadwaj A, Khuddus M, Caputo C, Korpas D, Cawich I, McAllister D, Blank N, Alraies MC, Fisher R, Khandelwal A, Alaswad K, Lemor A, Johnson T, Hacala M, O'Neill WW; National Cardiogenic Shock Initiative Investigators. Improved Outcomes Associated with the use of Shock Protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1173-1183. doi: 10.1002/ccd.28307. Epub 2019 Apr 25.
- Background: PubMed 36073018Ahlers MJ, Srivastava PK, Basir MB, O'Neill WW, Hacala M, Ammar K, Khalil S, Hollowed J, Nsair A. Characteristics and outcomes of patients presenting with acute myocardial infarction and cardiogenic shock during COVID-19. Catheter Cardiovasc Interv. 2022 Oct;100(4):568-574. doi: 10.1002/ccd.30390. Epub 2022 Sep 7.
- Henry Ford Hospital web page for NCSI/CERAMICSLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mir B Basir, DO principal investigator
Henry Ford Health
William W O'Neill, MD principal investigator
Henry Ford Health
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Acute Myocardial Infarction, run by Henry Ford Health System at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital discharge survival/survival at 30 days (time frame: Hospital discharge survival/survival at 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05800951, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.