Inova Cardiogenic Shock Registry (INOVA SHOCK) (INOVASHOCK)

Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry)

To collect retrospective clinical outcomes related to acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock and compare current versus historical survival rates.

To collect Inova Heart and Vascular Institute (IHVI) site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017.

To collect outcomes related to implementation of mechanical circulatory support versus no circulatory intervention and type of intervention (extracorporeal membrane oxygenation (ECMO) versus intracorporeal axial-flow (Impella).

• Assess survival at three time points.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Procedure: Cardiogenic Shock team activation

Detailed Description

Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute shall be included in this registry. This includes adults with and without decision making capacity over the age of 18 years old.

The primary investigator (PI) will designate the data points to be included in the database in order to assess the efficiency of procedures and protocols in the treatment of cardiogenic shock at the IHVI as administered by the Shock team, to identify relationships between treatment and negative morbidity and mortality outcomes, and to monitor and improve quality of care delivered.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Bhruga Shah; Phone Number: 703-776-2828; Email: bhruga.shah@inova.org

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Fairfax Hospital
      • Principal Investigator: Alex Truesdell, MD
      • Sub-Investigator: Benham Tehrani, MD
      • Contact: Behnam Tehrani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock

Description

Inclusion Criteria:

-Patients at the IHVI with documented Cardiogenic Shock team intervention for acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock.

Exclusion Criteria:

-Patients under the age of 18 will be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrospective review of Cardiogenic shock patients outcomes	To create an archive of retrospective clinical outcomes (acute decompensated heart failure cardiogenic shock, or acute myocardial infarction cardiogenic shock) and compare current versus historical survival rates.	1 Year

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Alexander Truesdell, MD, Inova Health Care Services; Principal Investigator: Behnam Tehrani, MD, Inova Health Care Services

Publications and helpful links

General Publications

• Sinha SS, Rosner CM, Tehrani BN, Maini A, Truesdell AG, Lee SB, Bagchi P, Cameron J, Damluji AA, Desai M, Desai SS, Epps KC, deFilippi C, Flanagan MC, Genovese L, Moukhachen H, Park JJ, Psotka MA, Raja A, Shah P, Sherwood MW, Singh R, Tang D, Young KD, Welch T, O'Connor CM, Batchelor WB. Cardiogenic Shock From Heart Failure Versus Acute Myocardial Infarction: Clinical Characteristics, Hospital Course, and 1-Year Outcomes. Circ Heart Fail. 2022 Jun;15(6):e009279. doi: 10.1161/CIRCHEARTFAILURE.121.009279. Epub 2022 May 5.
• Tehrani B, Truesdell A, Singh R, Murphy C, Saulino P. Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry): Observational and Retrospective Study. JMIR Res Protoc. 2018 Jun 28;7(6):e160. doi: 10.2196/resprot.9761.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: shock; cardiogenic
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: 172870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To facilitate both national and international research efforts in cardiogenic shock patient's collaborative studies may occur with other institutions outside of Inova.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No