Cardiogenic Shock Clinical Trial
— Team-ShockOfficial title:
Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre
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 |
Verified date | June 2022 |
Source | New Brunswick Heart Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Canada | New Brunswick Heart Centre | Saint John | New Brunswick |
Lead Sponsor | Collaborator |
---|---|
New Brunswick Heart Centre |
Canada,
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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