Inova Cardiogenic Shock Registry (INOVA SHOCK)

NCT ID: NCT03378739

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2099-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiogenic Shock

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inova Health Care Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Truesdell, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Behnam Tehrani, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Locations

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Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bhruga Shah

Role: CONTACT

703-776-2828

Facility Contacts

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Behnam Tehrani, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35510546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29954728 (View on PubMed)

Other Identifiers

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172870

Identifier Type: -

Identifier Source: org_study_id

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