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

Risk Stratification Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05066386
• Other study ID #: H-HHRatio-RCRI
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20099
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Risk Stratification

Intervention

Other:
• Modified RCRI risk stratification
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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