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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05414643
Other study ID # 101097
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2021
Est. completion date October 13, 2021

Study information

Verified date June 2022
Source New Brunswick Heart Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1416
Est. completion date October 13, 2021
Est. primary completion date October 13, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Standard care
No interventions were used, as this is an observational study.

Locations

Country Name City State
Canada New Brunswick Heart Centre Saint John New Brunswick

Sponsors (1)

Lead Sponsor Collaborator
New Brunswick Heart Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
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