Chronic Kidney Disease and Myocardial Injury After Non Cardiac Surgery (MINS)

February 11, 2022 updated by: Su-Yin MacDonell, University of British Columbia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing non cardiac surgery at St Paul's hospital.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Patients undergoing cardiac surgery.
  • Patients undergoing day surgery
  • Patients for whom Estimated Glomerular Filtration Rate (eGFR) results are not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Not an Interventional Study
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.
Other: Not an Interventional Study
Not an Interventional Study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Within 30 days post-operatively
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
Postoperative day 1 - 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cancellations of elective surgical cases for non-clinical reasons
Time Frame: From June 1, 2020 to December 31, 2021
Cancellations of elective surgical cases due to COVID-19 implications or staffing issues.
From June 1, 2020 to December 31, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Prabhakar, MD, University of British Columbia
  • Principal Investigator: Su-Yin MacDonell, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H21-00549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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