Improving the Accuracy of Revised Cardiac Risk Index With HbA1C:Hemoglobin Ratio (HH Ratio)

Retrospective observational study on the effects of altering components of RCRI to improve the predictive capacity.

Study Overview

• Status: Completed
• Conditions: Perioperative Medicine; Risk Stratification
• Intervention / Treatment: Other: Modified RCRI risk stratification

Detailed Description

The current Lee's Revised cardiac risk index (RCRI) was created in 1999. Validation studies have found RCRI to be only moderately discriminant. The "Diabetes Mellitus on insulin" component of the score does not accurately reflect the severity of the disease. A previously studied HbA1C:Hemoglobin ratio shows an improved association with outcomes than individual components alone and could be potentially used as a new marker for severity of the disease.

A retrospective cohort study was performed in consecutive diabetic patients undergoing non-cardiac surgery. Ethics approval was obtained. The objective of the study is to compare the predictive value of RCRI and substitution of the "DM on insulin" component with HH ratio for 30- and 90-day mortality, and postoperative acute myocardial injury(AMI) and acute kidney injury(AKI).

• Study Type: Observational
• Enrollment (Actual): 20099

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing non cardiac surgery in Singapore General Hospital

Description

• Above 18 years old
• Past medical history of Diabetes Mellitus or preoperative HbA1C > 6.5% (within 3 months of surgery)
• Had HbA1C done within 3 months prior to date of surgery
• Undergoing non cardiac surgery
• Emergency and elective surgery

EXCLUSION:

• If patient is below 18 years old
• no History of DM
• No HbA1C done within 3 months prior to date of surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	To compare the predictive value of RCRI and substitution of the "DM on insulin" component with HH ratio for 30- and 90-day mortality	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	To compare the predictive value of RCRI and substitution of the "DM on insulin" component with HH ratio for postoperative acute myocardial injury(AMI) and acute kidney injury(AKI).	7 days

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Risk model; HbA1C: Hemoglobin ratio (HH ratio); RCRI
• Other Study ID Numbers: H-HHRatio-RCRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Due to patient identifiers present in the dataset. Sensitive dataset

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No