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NCT03378739 Clinical Trial

Inova Cardiogenic Shock Registry (INOVA SHOCK)

Cardiogenic Shock Clinical Trial

— INOVASHOCK  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03378739
Other study ID # 172870
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2099

Study information
Verified date September 2023
Source Inova Health Care Services
Contact Bhruga Shah
Phone 703-776-2828
Email bhruga.shah@inova.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date December 31, 2099
Est. primary completion date December 31, 2099
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cardiogenic Shock team activation
Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute by the designated Cardiogenic Shock Team.

Locations
Country Name City State
United States Inova Fairfax Hospital Falls Church Virginia

Sponsors (1)
Lead Sponsor Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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