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Completed

NCT Number: NCT05066386

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Modified RCRI risk stratification

Other

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).

Primary outcomes

  1. Mortality

    Time frame: 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 outcomes

  1. Morbidity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Oct 4, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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