Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre (Team-Shock)

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.

Study Overview

• Status: Completed
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Other: Standard care

• Study Type: Observational
• Enrollment (Actual): 1416

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 4L2
      • New Brunswick Heart Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
At- risk group (SCAI stages A, B); Patients who had a SCAI stage A or B at any point during their stay at the New Brunswick Heart Centre, Saint John Regional Hospital. This group was compared with the cardiogenic shock group only for preliminary analysis.	Other: Standard care; No interventions were used, as this is an observational study.
Cardiogenic shock group (SCAI stages C-E); Patients who had a SCAI (Society for Cardiovascular Angiography and Interventions) stage C-E at any point during their stay at the New Brunswick Heart Centre, Saint John Regional Hospital. This group was used for all subsequent analyses.	Other: Standard care; No interventions were used, as this is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage mortality	Any in-hospital mortality (within Saint John Regional Hospital, another hospital after transfer)	From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Length of stay (LOS))	LOS was considered only for patients who were discharged directly home from Saint John Regional Hospital	From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Discharge disposition	Discharge of patients home, transfer to another hospital or to another institution (special care home, extra-mural home)	From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Percentage of missed opportunities	Missed opportunities was defined as patients who suffered significant delays or those who did not receive any intervention	From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from diagnosis of shock to in-hospital processes	Time gaps between the first diagnosis of a cardiogenic shock to in-hospital processes like invasive monitoring, cardiac catheterization or interventions (surgery, PCI, TAVI, IABP or ECMO).	From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months

Collaborators and Investigators

• Sponsor: New Brunswick Heart Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ACTUAL): October 13, 2021
• Study Completion (ACTUAL): October 13, 2021

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (ACTUAL): June 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: outcomes; ECMO; intervention; AMI; mortality; IABP; shock team; SCAI stage
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: 101097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No