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NCT03590223 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03590223
Other study ID # 2017-02156 (ch17berdajs)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 29, 2017
Est. completion date August 21, 2018

Study information
Verified date March 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 589
Est. completion date August 21, 2018
Est. primary completion date August 21, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012 Exclusion Criteria: - disapproval of use of data for research purposes

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Coronary Bypass Revascularization
analysis of perioperative major cardiovascular events in diabetic patients

Locations
Country Name City State
Switzerland Herzchirurgie University Hospital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary occurence of Major adverse cardiac events myocardial infarction, cardiac related death, stroke perioperative = in hospital
Secondary occurence of severe renal insufficiency application of renal replacement therapy (renal dialysis) perioperative = in hospital
Secondary occurence of sternal wound infection sternal wound infection perioperative = in hospital
Secondary mortality death rate perioperative perioperative = in hospital
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