Myocardial InjuryMINSNCT05248451
Chronic Kidney Disease and Myocardial Injury After Non Cardiac Surgery
An observational study of Myocardial Injury and Surgery, run by University of British Columbia at 1 site in Canada.
Trial summary
Investigators will conduct a retrospective chart review, examining the impact of chronic kidney disease on risk of myocardial injury after non cardiac surgery (MINS). The objective of this study is to examine interactions between preoperative Estimated Glomerular Filtration Rate (eGFR) and the association between… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myocardial Injury, Surgery, Chronic Kidney Diseases
- What is being tested?
- Not an Interventional Study
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2021to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing non cardiac surgery at St Paul's hospital.
Who may be able to join
- Patients undergoing non cardiac surgery, at St Paul's Hospital, during the period spanning June 1 2020 to November 30 2020
- Preoperative eGFR data is available, or chronic dialysis status is known (these patients will not reliably have eGFR measured, and it is not relevant)
- Inpatient surgeries (elective, urgent, and emergent)
Who cannot join
- Patients undergoing cardiac surgery.
- Patients undergoing day surgery
- Patients for whom Estimated Glomerular Filtration Rate (eGFR) results are not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Chronic Kidney Disease on Risk of Myocardial Injury After Non Cardiac Surgery (MINS). A Retrospective Chart Review.
Investigators will conduct a retrospective chart review, examining the impact of chronic kidney disease on risk of myocardial injury after non cardiac surgery (MINS). The objective of this study is to examine interactions between preoperative Estimated Glomerular Filtration Rate (eGFR) and the association between preoperative N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) and post operative cardiac events in patients undergoing major non cardiac surgery.
Read the detailed description
In recent years some authors have shown a correlation between increased post operative troponin and increased 30 day mortality in patients with kidney disease that mirrors the known correlation in those with normal renal function. In patients undergoing non cardiac surgery, Walsh et al demonstrated a 4 to 6 fold increased risk of death associated with elevated post operative troponin in patients with reduced (<60 ml/min, but >30ml/min) preoperative estimated glomerular filtration rate (eGFR). A second, more recent study by Liem et al, also found post operative troponin elevations were associated with higher morbidity and mortality risk in patients with chronic kidney disease undergoing non cardiac surgery. Investigators aim to build upon the findings of these authors by examining the relationship between pre operative eGFR, post operative troponin and risk of post operative cardiac events in patients undergoing non cardiac surgery at St Paul's hospital. Investigators will conduct a retrospective chart review of electronic records for all patients undergoing non cardiac, inpatient surgery at St Paul's Hospital from June 1, 2020 to December 31, 2021). Investigators will include all patients for whom preoperative eGFR values are available, and patients on chronic dialysis. Patients are to be stratified by preoperative eGFR and primary outcomes compared between patients with normal vs abnormal preoperative eGFR. Primary outcomes to be reviewed are myocardial injury after non cardiac surgery (MINS) and troponin elevations.
- Conditions
- Myocardial Injury, Surgery, Chronic Kidney Diseases
- Being tested
- Not an Interventional Study
- Keywords
- MINS, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not an Interventional StudyOther
Not an Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Normal Renal Function | Patients undergoing inpatient non-cardiac surgery at St. Paul's Hospital with normal preoperative Estimated Glomerular Filtration Rate (eGFR) results. eGFR values considered will be from samples drawn within a one year period preceding surgery. Values from samples drawn within the 7 days immediately preceding surgery will be excluded, in order to avoid introducing bias from acute kidney injuries. All available eGFR values in the 7 to 365 days preceding an individual's surgery will be included, and the average of these values will be used as their preoperative eGFR. Investigators will include all people that have one or more measure. Depending on sample size, investigators may decide to limit inclusion to those that have two or more eGFR estimates. Receives: Other: Not an Interventional Study | |
| Renal Dysfunction, Chronic Kidney Disease (CKD) | Patients undergoing non-cardiac surgery with abnormal preoperative Estimated Glomerular Filtration Rate (eGFR). eGFR values considered will be from samples drawn within a one year period preceding surgery. Values from samples drawn within the 7 days immediately preceding surgery will be excluded, in order to avoid introducing bias from acute kidney injuries. All available eGFR values in the 7 to 365 days preceding an individual's surgery will be included, and the average of these values will be used as their preoperative eGFR. Investigators will include all people that have one or more measure. Depending on sample size, investigators may decide to limit inclusion to those that have two or more eGFR estimates. As eGFR is not accurate in the setting of dialysis, patients receiving dialysis for at least 90 days prior to their surgical procedure will also be included as a separate eGFR category. Receives: Other: Not an Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury after non cardiac surgery (MINS)
Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions
Measured: Within 30 days post-operatively
Troponin Elevation
Post-operative high sensitivity Troponin T (hs-TnT) of 20 ng/L to 65 ng/L with an absolute increase of at least 5 ng/L or any concentration > 65 ng/L
Measured: Postoperative day 1 - 3
Secondary outcomes (1)
Cancellations of elective surgical cases for non-clinical reasons
Cancellations of elective surgical cases due to COVID-19 implications or staffing issues.
Measured: From June 1, 2020 to December 31, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start22 Jun 2021
- Primary completion22 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-Yin MacDonell, University of British Columbia
- Investigators
- Christopher Prabhakar, MD, Principal investigator, University of British ColumbiaSu-Yin MacDonell, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248451
- Sponsor's protocol ID
- H21-00549
- Acronym
- MINS
- Status last verified
- Jan 2022
- First submitted
- 11 Feb 2022
- Last updated
- 21 Feb 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 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chronic Kidney Disease on Risk of Myocardial Injury After Non Cardiac Surgery (MINS). A Retrospective Chart Review.
- ClinicalTrials.gov ID
- NCT05248451
- Acronym / sponsor ID
- MINS / H21-00549
- Conditions
- Myocardial Injury, Surgery, Chronic Kidney Diseases
- Keywords
- MINS, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 22 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Feb 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.
Investigators will conduct a retrospective chart review, examining the impact of chronic kidney disease on risk of myocardial injury after non cardiac surgery (MINS). The objective of this study is to examine interactions between preoperative Estimated Glomerular Filtration Rate (eGFR) and the association between preoperative N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) and post operative cardiac events in patients undergoing major non cardiac surgery.
Detailed description
In recent years some authors have shown a correlation between increased post operative troponin and increased 30 day mortality in patients with kidney disease that mirrors the known correlation in those with normal renal function. In patients undergoing non cardiac surgery, Walsh et al demonstrated a 4 to 6 fold increased risk of death associated with elevated post operative troponin in patients with reduced (<60 ml/min, but >30ml/min) preoperative estimated glomerular filtration rate (eGFR). A second, more recent study by Liem et al, also found post operative troponin elevations were associated with higher morbidity and mortality risk in patients with chronic kidney disease undergoing non cardiac surgery. Investigators aim to build upon the findings of these authors by examining the relationship between pre operative eGFR, post operative troponin and risk of post operative cardiac events in patients undergoing non cardiac surgery at St Paul's hospital. Investigators will conduct a retrospective chart review of electronic records for all patients undergoing non cardiac, inpatient surgery at St Paul's Hospital from June 1, 2020 to December 31, 2021). Investigators will include all patients for whom preoperative eGFR values are available, and patients on chronic dialysis. Patients are to be stratified by preoperative eGFR and primary outcomes compared between patients with normal vs abnormal preoperative eGFR. Primary outcomes to be reviewed are myocardial injury after non cardiac surgery (MINS) and troponin elevations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Renal Function | – | Other: Not an Interventional StudyPatients undergoing inpatient non-cardiac surgery at St. Paul's Hospital with normal preoperative Estimated Glomerular Filtration Rate (eGFR) results. eGFR values considered will be from samples drawn within a one year period preceding surgery. Values from samples drawn within the 7 days immediately preceding surgery will be excluded, in order to avoid introducing bias from acute kidney injuries. All available eGFR values in the 7 to 365 days preceding an individual's surgery will be included, and the average of these values will be used as their preoperative eGFR. Investigators will include all people that have one or more measure. Depending on sample size, investigators may decide to limit inclusion to those that have two or more eGFR estimates. |
| Renal Dysfunction, Chronic Kidney Disease (CKD) | – | Other: Not an Interventional StudyPatients undergoing non-cardiac surgery with abnormal preoperative Estimated Glomerular Filtration Rate (eGFR). eGFR values considered will be from samples drawn within a one year period preceding surgery. Values from samples drawn within the 7 days immediately preceding surgery will be excluded, in order to avoid introducing bias from acute kidney injuries. All available eGFR values in the 7 to 365 days preceding an individual's surgery will be included, and the average of these values will be used as their preoperative eGFR. Investigators will include all people that have one or more measure. Depending on sample size, investigators may decide to limit inclusion to those that have two or more eGFR estimates. As eGFR is not accurate in the setting of dialysis, patients receiving dialysis for at least 90 days prior to their surgical procedure will also be included as a separate eGFR category. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing non cardiac surgery at St Paul's hospital.
Key inclusion criteria (3 listed)
- Patients undergoing non cardiac surgery, at St Paul's Hospital, during the period spanning June 1 2020 to November 30 2020
- Preoperative eGFR data is available, or chronic dialysis status is known (these patients will not reliably have eGFR measured, and it is not relevant)
- Inpatient surgeries (elective, urgent, and emergent)
Key exclusion criteria (3 listed)
- Patients undergoing cardiac surgery.
- Patients undergoing day surgery
- Patients for whom Estimated Glomerular Filtration Rate (eGFR) results are not available
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 |
|---|---|---|
| Not an Interventional StudyNot an Interventional Study | Other | Normal Renal Function, Renal Dysfunction, Chronic Kidney Disease (CKD) |
Primary outcome
Myocardial injury after non cardiac surgery (MINS)
Time frame: Within 30 days post-operatively
Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions
Troponin Elevation
Time frame: Postoperative day 1 - 3
Post-operative high sensitivity Troponin T (hs-TnT) of 20 ng/L to 65 ng/L with an absolute increase of at least 5 ng/L or any concentration > 65 ng/L
1 secondary outcome
Cancellations of elective surgical cases for non-clinical reasons
Time frame: From June 1, 2020 to December 31, 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Myocardial Injury
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
RecruitingObservational study
Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation
Atrial Fibrillation (AF)
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.
Christopher Prabhakar, MD principal investigator
University of British Columbia
Su-Yin MacDonell, MD principal investigator
University of British Columbia
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 Myocardial Injury and Surgery, run by University of British Columbia 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Feb 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?
Results are not available in the source record.
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?
Myocardial injury after non cardiac surgery (MINS) (time frame: Within 30 days post-operatively). The study lists 2 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 21 Feb 2022.