Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

Acute Myocardial Infarction Clinical Trial

— CERAMICS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05800951
• Other study ID #: CERAMICS
• Status: Enrolling by invitation
• Start date: July 22, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI).

2. 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

3. 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:

1. Evidence of Anoxic Brain Injury

2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes

3. IABP placed prior to MCS

4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock

5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)

6. Active bleeding for which MCS is contraindicated

7. Recent major surgery for which MCS is contraindicated

8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)

9. Known left ventricular thrombus for which MCS is contraindicated

10. Mechanical aortic prosthetic valve

11. Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Acute Myocardial Infarction With ST Elevation
• Cardiogenic Shock
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• NSTEMI
• NSTEMI - Non-ST Segment Elevation MI
• Shock
• Shock, Cardiogenic
• ST Elevation Myocardial Infarction
• STEMI
• STEMI - ST Elevation Myocardial Infarction

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Abiomed Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital discharge survival/survival at 30 days	Hospital discharge survival/survival at 30 days	Hospital discharge survival/survival at 30 days
Secondary	All-cause mortality at 1 year	All-cause mortality at 1 year	All-cause mortality at 1 year

External Links

•   Henry Ford Hospital web page for NCSI/CERAMICS