NCT05414643

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 14, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

April 14, 2022

Last Update Submit

June 8, 2022

Conditions

Keywords

mortalityoutcomesAMIshock teamSCAI stageinterventionIABPECMO

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Time from diagnosis of shock to in-hospital processes

    From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months

Study Arms (2)

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

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

Interventions

No interventions were used, as this is an observational study.

At- risk group (SCAI stages A, B)Cardiogenic shock group (SCAI stages C-E)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Brunswick Heart Centre

Saint John, New Brunswick, E2L 4L2, Canada

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jean-François Légaré, M.D., Ph.D.

    New Brunswick Heart Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiac Surgery

Study Record Dates

First Submitted

April 14, 2022

First Posted

June 10, 2022

Study Start

January 14, 2021

Primary Completion

October 13, 2021

Study Completion

October 13, 2021

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations