NCT03378739

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
896mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jan 2018Dec 2099

First Submitted

Initial submission to the registry

December 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
82.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2099

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

82.1 years

First QC Date

December 12, 2017

Last Update Submit

March 12, 2026

Conditions

Cardiogenic Shock

Keywords

cardiogenicshock

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Cardiogenic Shock team activationPROCEDURE

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Patients under the age of 18 will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35510546DERIVED

  • 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.

    PMID: 29954728DERIVED

MeSH Terms

Conditions

Shock, CardiogenicShock

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Vanessa Blumer, MD

    Inova Health Care Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhruga Shah

CONTACT

703-776-2828bhruga.shah@inova.org

Study Design

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

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 20, 2017

Study Start

January 1, 2018

Primary Completion (Estimated)

December 31, 2099

Study Completion (Estimated)

December 31, 2099

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

To facilitate both national and international research efforts in cardiogenic shock patient's collaborative studies may occur with other institutions outside of Inova.

Shared Documents
CSR

Locations

US(1)