Chronic Kidney Disease and Myocardial Injury After Non Cardiac Surgery

Surgery Clinical Trial

— MINS  

Official title:

The Impact of Chronic Kidney Disease on Risk of Myocardial Injury After Non Cardiac Surgery (MINS). A Retrospective Chart Review.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05248451
• Other study ID #: H21-00549
• Status: Active, not recruiting
• Start date: June 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 preoperative N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) and post operative cardiac events in patients undergoing major non cardiac surgery.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Myocardial Injury
• Renal Insufficiency, Chronic
• Surgery
• Wounds and Injuries

Intervention

Other:
• Not an Interventional Study
Not an Interventional Study

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial injury after non cardiac surgery (MINS)	Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions	Within 30 days post-operatively
Primary	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	Postoperative day 1 - 3
Secondary	Cancellations of elective surgical cases for non-clinical reasons	Cancellations of elective surgical cases due to COVID-19 implications or staffing issues.	From June 1, 2020 to December 31, 2021