NCT03590223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 29, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

July 4, 2018

Last Update Submit

March 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • occurence of Major adverse cardiac events

    myocardial infarction, cardiac related death, stroke

    perioperative = in hospital

Secondary Outcomes (3)

  • occurence of severe renal insufficiency

    perioperative = in hospital

  • occurence of sternal wound infection

    perioperative = in hospital

  • mortality

    perioperative = in hospital

Interventions

analysis of perioperative major cardiovascular events in diabetic patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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%

You may qualify if:

  • patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012

You may not qualify if:

  • disapproval of use of data for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzchirurgie University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

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

    RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Denis Berdajs, PD Dr. med

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 18, 2018

Study Start

December 29, 2017

Primary Completion

August 21, 2018

Study Completion

August 21, 2018

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations