Carolinas Cardiogenic Shock Initiative

NCT04985708 | Completed

• 2 other identifiers: IRB00082325011913E
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiogenic Shock; Acute; Myocardial Infarction, Complications

Keywords

cardiogenic shock; Impella; shock severity index

Outcome Measures

Primary Outcomes (1)

• Survival at 30-days

  Survival at 30 days post procedure

  30 days

Study Arms (3)

Patient with AMICS are likely to benefit from MCS

later

Other: data collection of clinically available procedures

Develop and maintain a patient registry of AMICS

later

Other: data collection of clinically available procedures

Classify patients based on shock severity.

later

Other: data collection of clinically available procedures

Interventions

data collection of clinically available procedures OTHER

when to place Impella related to PCI in patients with AMICS

Also known as: Impella timing

Classify patients based on shock severity.; Develop and maintain a patient registry of AMICS; Patient with AMICS are likely to benefit from MCS

Eligibility Criteria

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

Study Population

We have no reason to assume the patients who present with AMICS, will not be representative of the demographics of the region in which the participating site(s) are located. For this reason, we will not prioritize enrollment or recruitment based on demographics. Patients who present to the cardiac catheterization lab with AMICS at participating sites, and who meet inclusion criteria, will be included in the registry upon discharge. Data will be gathered in the usual manner for clinical purposes, for patients who die during their admission. The duration of the patient's enrollment in the registry is anticipated to last 1 year from AMICS. Recording of data in the registry is anticipated to last approximately 3 years.

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Glen J Kowalchuk, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: May 1, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 6, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)