CCSI: Carolinas Cardiogenic Shock Initiative

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04985708

Collaborator

(none)

120

Enrollment

Location

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if deferred or delayed implantation of Impella device based on shock severity index is non-inferior with respect to 1 month and 1 year mortality compared to standard clinical protocols that do not differentiate based on shock severity in adult patients following an initial diagnosis of acute myocardial infarction complicated by cardiogenic shock (AMICS).

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock Acute; Myocardial Infarction, Complications	Other: data collection of clinically available procedures

Detailed Description

The Carolinas Cardiogenic Shock Initiative is a clinical pathway and process improvement protocol already agreed upon by participating sites, to improve care by using a standardized algorithm to treat patients with AMI and CS. This prospective registry will capture data from this protocol as a multi-site research project in parallel with this standardized non-research clinic workflow protocol. Participating providers will follow the clinical protocol as standard of care for AMICS patients, as clinically appropriate. Patients who have been admitted and diagnosed with AMICS and meet all eligibility criteria will have their data entered in this registry.

All eligible patients who are discharged alive from the hospital will be entered into the registry and follow-up via the EMR and/or SSDI will occur at 30 days and one year to assess mortality. No additional provider appointments or further testing will be required as a part of this Registry, other than what each provider feels is medically necessary and indicated as a part of the patients' care plan.

Treatment decisions and timing will follow an approved clinical protocol and algorithm (see Appendix A) based on shock severity classification. The research team at each site will capture data generated during standard of care lab tests and clinical procedures, as well as data collected during clinical visits from eligible patients. Our target accrual is approximately 672 patients, cumulative across all participating sites.

Many of the patient specific outcomes and variables of interest for this study, are already submitted to the National Cardiovascular Data Registry (NCDR). Some additional data elements, as described in Apendix C, will also be captured. There are no benefits in participation other than the scientific knowledge gained, and the only alternative to participation is not participating.

4.1.1 Primary Outcome Variable The primary outcome variable will be 30-day all cause mortality. 4.1.2 Secondary Outcome Variable(s)

Key secondary outcome variables for analysis may include but are not limited to:

One year mortality
length of ICU care
requirement for renal replacement therapy
dose and duration of catecholamine therapy
requirement for implantation of an active LVAD or referral for cardiac transplantation
time to support (arrival to tertiary facility to implantation)
use of right heart catheterization
Attainment of TIMI III flow post reperfusion
Attainment of Cardiac power > 0.6 watts after completion of therapy
Reduction or elimination of vasopressors and inotropic agents.
blood products during admission
hemolysis requiring device discontinuation
vascular complication requiring surgery

Study Procedures:

All inpatient data on eligible patients will come from the hospital inpatient records. Once the patient is deemed eligible, their clinical data will be entered or migrated into the research registry. Additional data will be collected at approximately one month and one year following AMICS, using the EMR and the SSDI.

The following are some of the variables which will be collected and recorded within the registry:

Demographics
Medical history
Admission characteristics
Diagnostic values
Procedure dates and times
Procedure characteristics
Post-procedure information
Discharge survival
Survival at 1 month from AMICS
Survival at 12 months from AMICS
Additional Quality Metrics

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Carolinas Cardiogenic Shock Initiative

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patient with AMICS are likely to benefit from MCS later	Other: data collection of clinically available procedures when to place Impella related to PCI in patients with AMICS Other Names: Impella timing
Develop and maintain a patient registry of AMICS later	Other: data collection of clinically available procedures when to place Impella related to PCI in patients with AMICS Other Names: Impella timing
Classify patients based on shock severity. later	Other: data collection of clinically available procedures when to place Impella related to PCI in patients with AMICS Other Names: Impella timing

Arm

Intervention/Treatment

Patient with AMICS are likely to benefit from MCS

later

Other: data collection of clinically available procedures

when to place Impella related to PCI in patients with AMICS

Other Names:

Impella timing

Develop and maintain a patient registry of AMICS

later

Other: data collection of clinically available procedures

when to place Impella related to PCI in patients with AMICS

Other Names:

Impella timing

Classify patients based on shock severity.

later

Other: data collection of clinically available procedures

when to place Impella related to PCI in patients with AMICS

Other Names:

Impella timing

Outcome Measures

Primary Outcome Measures

Survival at 30-days [30 days]
Survival at 30 days post procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of S-T elevation myocardial infarction (STEMI) or non-S-T elevation myocardial infarction (NSTEMI)
Systolic blood pressure < 90mm at baseline or use of inotropes or vasopressors to maintain SBP > 90 + LVEDP > 15
Evidence of end organ hypoperfusion
Patient undergoes PCI

Exclusion Criteria:

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 in 30 minutes
IABP placed prior to Impella
Patient is already supported with an Impella
Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
Active bleeding for which mechanical circulatory support is contraindicated
Recent major surgery for which mechanical circulatory support is contraindicated
Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
Known left ventricular thrombus for which mechanical circulatory support is contraindicated
Mechanical aortic prosthetic valve
Contraindication to intravenous systemic anticoagulation