Cardiovascular EventNCT03590223
Glycosylated Hemoglobin and Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization (HbA1c)
An observational study of Cardiovascular Event and Coronary Artery Bypass Graft, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Event, Coronary Artery Bypass Graft, Diabetes Mellitus
- What is being tested?
- Coronary Bypass Revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 589 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Dec 2017to 21 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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%
Who may be able to join
- patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012
Who cannot join
- disapproval of use of data for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Coronary Bypass Revascularization
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Bypass RevascularizationProcedure or surgery
analysis of perioperative major cardiovascular events in diabetic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of Major adverse cardiac events
myocardial infarction, cardiac related death, stroke
Measured: perioperative = in hospital
Secondary outcomes (3)
occurence of severe renal insufficiency
application of renal replacement therapy (renal dialysis)
Measured: perioperative = in hospital
occurence of sternal wound infection
sternal wound infection
Measured: perioperative = in hospital
mortality
death rate perioperative
Measured: perioperative = in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start29 Dec 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular EventStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Berdajs, PD Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590223
- Sponsor's protocol ID
- 2017-02156 (ch17berdajs)
- Other IDs
- 2017
- Status last verified
- Mar 2021
- First submitted
- 4 Jul 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
https://www.pulsus.com/scholarly-articles/glycosylated-hemoglobin-and-adverse-events-following-elective-coronary-bypass-revascularization-4682.html
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycosylated Hemoglobin and the Risk of Perioperative Major Cardiovascular Events in Diabetic Patients Undergoing Coronary Bypass Revascularization
- ClinicalTrials.gov ID
- NCT03590223
- Acronym / sponsor ID
- 2017-02156 (ch17berdajs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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%
Key inclusion criteria (1 listed)
- patients with Diabetes mellitus undergoing coronary bypass revascularization since 2012
Key exclusion criteria (1 listed)
- disapproval of use of data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Bypass Revascularizationanalysis of perioperative major cardiovascular events in diabetic patients | Procedure or surgery | – |
Primary outcome
occurence of Major adverse cardiac events
Time frame: perioperative = in hospital
myocardial infarction, cardiac related death, stroke
3 secondary outcomes
occurence of severe renal insufficiency
Time frame: perioperative = in hospital
occurence of sternal wound infection
Time frame: perioperative = in hospital
mortality
Time frame: perioperative = in hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Results publicationhttps://www.pulsus.com/scholarly-articles/glycosylated-hemoglobin-and-adverse-events-following-elective-coronary-bypass-revascularization-4682.html
Related trials for Cardiovascular Event
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Berdajs, PD Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Event and Coronary Artery Bypass Graft, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence of Major adverse cardiac events (time frame: perioperative = in hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.