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

Sponsor
Singapore General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05066386
Collaborator
(none)
20,099
Enrollment
103
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20099 participants
Observational Model:
Cohort
Time Perspective:
Other
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Aug 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Mortality [90 days]

    To compare the predictive value of RCRI and substitution of the "DM on insulin" component with HH ratio for 30- and 90-day mortality

Secondary Outcome Measures

  1. Morbidity [7 days]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Singapore General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT05066386
Other Study ID Numbers:
  • H-HHRatio-RCRI
First Posted:
Oct 4, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Singapore General Hospital
HbA1C: Hemoglobin ratio (HH ratio)
Risk model
RCRI

Study Results

No Results Posted as of Oct 4, 2021