CERAMICS: Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

Sponsor

Henry Ford Health System (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05800951

Collaborator

Abiomed Inc. (Industry)

120

Enrollment

Locations

29.3

Anticipated Duration (Months)

7.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

Hospital discharge survival/survival at 30 days [Hospital discharge survival/survival at 30 days]
Hospital discharge survival/survival at 30 days

Secondary Outcome Measures

All-cause mortality at 1 year [All-cause mortality at 1 year]
All-cause mortality at 1 year

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354
2	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
3	Providence St. Joseph Hospital Orange	Orange	California	United States	92868
4	St. Anthony Hospital	Lakewood	Colorado	United States	80228
5	George Washington University Hospital	Washington	District of Columbia	United States	20037
6	Northside Hospital Atlanta	Atlanta	Georgia	United States	30342
7	St. Elizabeth Edgewood Hospital	Edgewood	Kentucky	United States	41017
8	Henry Ford Hospital	Detroit	Michigan	United States	48202
9	Ascenion St. John Hospital	Detroit	Michigan	United States	48236
10	Spectrum Health Hospitals Fred and Lena Meijer Heart Center	Grand Rapids	Michigan	United States	49503
11	Hackensack Meridian Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
12	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
13	Fort Sanders Regional Medical Center	Knoxville	Tennessee	United States	37916
14	TriStar Centennial Medical Center	Nashville	Tennessee	United States	37203
15	Parkwest Medical Center	Nashville	Tennessee	United States	37923
16	Methodist Hospital	San Antonio	Texas	United States	78229
17	UVA University Hospital	Charlottesville	Virginia	United States	22903