Glycosylated Hemoglobin and Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization (HbA1c)

Glycosylated Hemoglobin and the Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization

Glycosylated Hemoglobin (HbA1c) is considered as one of the best markers to assess the glycaemia treatment over a period of 3 to 4 months, and is considered as predictive marker for perioperative mortality and morbidity. The impact of the elevated HbA1c on the risk of perioperative major cardiovascular events in patients undergoing coronary bypass revascularization (by retrospective analysis of perioperative cardiovascular events and preoperative HbA1c) is evaluated.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Coronary Artery Bypass Graft; Cardiovascular Event
• Intervention / Treatment: Procedure: Coronary Bypass Revascularization

• Study Type: Observational
• Enrollment (Actual): 589

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Herzchirurgie University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patients with diabetes mellitus

• undergoing coronary bypass revascularization at the Klinik für Herzchirurgie, Universitätsspital Basel, Spitalstrasse 21, CH 4031-Basel since 2012
• who did not disapprove of use of data for research purposes
• statistic stratification in serum level of glycosylated hemoglobin (HbA1c) > 6.5% and </= 6.5%

Description

Inclusion Criteria:

• patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012

Exclusion Criteria:

• disapproval of use of data for research purposes

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence of Major adverse cardiac events	myocardial infarction, cardiac related death, stroke	perioperative = in hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence of severe renal insufficiency	application of renal replacement therapy (renal dialysis)	perioperative = in hospital
occurence of sternal wound infection	sternal wound infection	perioperative = in hospital
mortality	death rate perioperative	perioperative = in hospital

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Denis Berdajs, PD Dr. med, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• https://www.pulsus.com/scholarly-articles/glycosylated-hemoglobin-and-adverse-events-following-elective-coronary-bypass-revascularization-4682.html

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2017
• Primary Completion (Actual): August 21, 2018
• Study Completion (Actual): August 21, 2018

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017-02156 (ch17berdajs)

Drug and device information, study documents

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