Clinical trial NCT03378739: Inova Cardiogenic Shock Registry (INOVA SHOCK)
Official title: Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Keywords: cardiogenic
shock
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retrospective review of Cardiogenic shock patients outcomes
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Alexander Truesdell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Behnam Tehrani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.