Cardiogenic ShockTeam-ShockNCT05414643
Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre
An observational study of Cardiogenic Shock, run by New Brunswick Heart Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiogenic Shock
- How many people
- 1,416 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2021to 13 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiogenic Shock
- Being tested
- Standard care
- Keywords
- mortality, outcomes, AMI, shock team, SCAI stage, intervention, IABP, ECMO
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
No interventions were used, as this is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage mortality
Any in-hospital mortality (within Saint John Regional Hospital, another hospital after transfer)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
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).
Measured: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start14 Jan 2021
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Brunswick Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jean-François Légaré, New Brunswick Heart Centre
- Investigators
- Jean-François Légaré, M.D., Ph.D., Principal investigator, New Brunswick Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414643
- Sponsor's protocol ID
- 101097
- Acronym
- Team-Shock
- Status last verified
- Jun 2022
- First submitted
- 14 Apr 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Acute Cardiogenic Shock at the New Brunswick Heart Centre
- ClinicalTrials.gov ID
- NCT05414643
- Acronym / sponsor ID
- Team-Shock / 101097
- Conditions
- Cardiogenic Shock
- Keywords
- mortality, outcomes, AMI, shock team, SCAI stage, intervention, IABP, ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,416 participants (actual)
- Lead sponsor
- New Brunswick Heart CentreUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At- risk group (SCAI stages A, B) | – | Other: Standard carePatients 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. |
| Cardiogenic shock group (SCAI stages C-E) | – | Other: Standard carePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard careNo interventions were used, as this is an observational study. | Other | At- risk group (SCAI stages A, B), Cardiogenic shock group (SCAI stages C-E) |
Primary outcome
Percentage mortality
Time frame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Any in-hospital mortality (within Saint John Regional Hospital, another hospital after transfer)
Length of stay (LOS))
Time frame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
LOS was considered only for patients who were discharged directly home from Saint John Regional Hospital
Discharge disposition
Time frame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Discharge of patients home, transfer to another hospital or to another institution (special care home, extra-mural home)
Percentage of missed opportunities
Time frame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Missed opportunities was defined as patients who suffered significant delays or those who did not receive any intervention
1 secondary outcome
Time from diagnosis of shock to in-hospital processes
Time frame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Légaré, M.D., Ph.D. principal investigator
New Brunswick Heart Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by New Brunswick Heart Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage mortality (time frame: From the date of hospital admission at Saint John Regional Hospital to the date of discharge, assessed upto 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.