Clinical trial NCT05414643: Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre
Official title: Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Keywords: mortality
outcomes
AMI
shock team
SCAI stage
intervention
IABP
ECMO
Lead sponsor: New Brunswick Heart Centre
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 1416
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were admitted to the CCU at the NBHC, Saint John Regional Hospital between November 1st 2019 to November 30th 2020 were included in the study.

Brief summary: In Atlantic Canada, acute myocardial infarction occurs at a rate of 2.9 % of the population and is the most common cause of cardiogenic shock (CS). In many studies, acute myocardial infarction accounts for up to 80% of the patients with CS. While there are different methods of treating patients with CS, the rate of mortality has not significantly improved over the years and remains as high as 50%. Recent studies have shown that a multi-modal, team-based approach can help improve patient outcomes; however, such a standardized approach is yet to be implemented in the New Brunswick Heart Centre (NBHC).

The study aims to understand the difference in outcomes between two groups of patients treated for CS: SHOCK TEAM versus non-SHOCK TEAM. This is a retrospective study of 168 patients using the data from NBHC registry and patient charts. The study duration is 1 year. The primary outcome is hospital survival. Secondary outcomes include time from diagnosis to invasive monitoring and intervention. All data will be analyzed statistically between the two groups. The end goal of the study is to establish standard guidelines to treat CS patients and improve patient survival.


Eligibility criteria: Inclusion Criteria:

1) Any patient admitted to the CCU with a diagnosis of CS (SCAI groups C, D or E) at any point during their CCU care.

Exclusion Criteria:

1) CS patients having SCAI groups A, B (this group was used only for preliminary analysis, hence this is the exclusion criteria for all final analyses).

Primary outcomes:
measure: Percentage mortality
timeFrame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
measure: Length of stay (LOS))
timeFrame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
measure: Discharge disposition
timeFrame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
measure: Percentage of missed opportunities
timeFrame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Secondary outcomes:
measure: Time from diagnosis of shock to in-hospital processes
timeFrame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
Study officials:
affiliation: New Brunswick Heart Centre
name: Jean-François Légaré, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: