Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

NCT05800951 | Active Not Recruiting

• 1 other identifier: CERAMICS
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 17

Brief 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 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hospital discharge survival/survival at 30 days

  Hospital discharge survival/survival at 30 days

  Hospital discharge survival/survival at 30 days

Secondary Outcomes (1)

• All-cause mortality at 1 year

  All-cause mortality at 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who present with an acute myocardial infarction (AMI) with cardiogenic shock (AMICS) prior to PCI.

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead
• Abiomed Inc.: collaborator

Study Sites (17)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Providence St. Joseph Hospital Orange

Orange, California, 92868, United States

Location

St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Northside Hospital Atlanta

Atlanta, Georgia, 30342, United States

Location

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, 41017, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascenion St. John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum Health Hospitals Fred and Lena Meijer Heart Center

Grand Rapids, Michigan, 49503, United States

Location

Hackensack Meridian Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

Location

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Parkwest Medical Center

Nashville, Tennessee, 37923, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

UVA University Hospital

Charlottesville, Virginia, 22903, United States

Location

Related Publications (6)

• 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.

  PMID: 29266676 BACKGROUND

• Hanson 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.

  PMID: 32672388 BACKGROUND

• Goldsweig 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.

  PMID: 33358390 BACKGROUND

• Lemor 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.

  PMID: 33606413 BACKGROUND

• Basir 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.

  PMID: 31025538 BACKGROUND

• Ahlers 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.

  BACKGROUND

Related Links

• Henry Ford Hospital web page for NCSI/CERAMICS

MeSH Terms

Conditions

Shock, Cardiogenic; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Mir B Basir, DO

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

• William W O'Neill, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Acute Mechanical Circulatory Support Program and STEMI Programs

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: April 6, 2023
• Study Start: July 22, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)