Coronary Artery Disease, DiabetesNCT03543449
Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.
An observational study of Coronary Artery Disease, Diabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate evaluated the impact of preoperative HbA1c in diabetic patients on perioperative glycemic variability and outcome after off-pump coronary artery bypass (OPCAB). Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes
- What is being tested?
- Off-Pump Coronary Artery Bypass (OPCAB) surgery
- How many people
- 703 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2018to Apr 2019
- 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 20 to 89 years
- All sexes
- Adult, Older adult
Study population: Patients with a history of preoperative diabetes mellitus
Who may be able to join
- Patients with a history of preoperative diabetes mellitus and with available results of HbA1c test within 3 months before surgery.
- Patients who aged 20 to 89 years
Who cannot join
- Patient who had a history of previous coronary artery bypass surgery
- Patients whose surgery plan changed to cardiopulmonary bypass during surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology & Pain Medicine, Yonsei university college of medicine
Seoul, 120-752
About this study
The aim of this study is to evaluate evaluated the impact of preoperative HbA1c in diabetic patients on perioperative glycemic variability and outcome after off-pump coronary artery bypass (OPCAB).
The medical records of patients who had a preoperative diagnosis of diabetes and underwent OPCAB from 2005 to 2017 will be reviewed. Patients are divided by HbA1c levels (<7.0% or ≥7.0%). Glycemic variability during surgery and up to 24 hours after surgery is assessed by the coefficient of variation. The primary outcome is defined as a composite of postoperative permanent stroke, prolonged ventilation, deep sternal wound infection, renal failure, reoperation, mortality according to the definition of STS (Society of Thoracic Surgery) version 2.81 adult cardiac surgery database. If one or more of the above five morbidity or mortality occur, it is assumed that composite morbidity/mortality had occurred. We compare postoperative complications, mortality and perioperative glycemic variability between patients with HbA1c ≥7.0% and <7.0%, and examined the effects of perioperative glycemic control on postoperative morbidity and mortality (composite morbidity/mortality).
- Conditions
- Coronary Artery Disease, Diabetes
- Being tested
- Off-Pump Coronary Artery Bypass (OPCAB) surgery
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-Pump Coronary Artery Bypass (OPCAB) surgeryOther
Off-Pump Coronary Artery Bypass (OPCAB) surgery. This study is retrospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Permanent stroke
postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.)
Measured: during the hospitalization for surgery (up to 30 days)
Incidence of Renal failure
- Increase in serum creatinine level 3.0 x greater than baseline, or serum creatinine level ≥ 4 mg/dL. The acute rise must be at least 0.5 mg/dl.
- A new requirement for dialysis postoperatively.
Measured: during the hospitalization for surgery (up to 30 days)
Incidence of Prolonged ventilation
Prolonged post-operative pulmonary ventilation > 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.
Measured: during the hospitalization for surgery (up to 30 days)
Incidence of Deep sternal wound infection
Deep sternal wound infection or mediastinitis including muscle layer according to CDC definition
Measured: during the hospitalization for surgery (up to 30 days)
Incidence of Re-operation for any reason
reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason
Measured: during the hospitalization for surgery (up to 30 days)
Operative mortality
all deaths, regardless of cause
Measured: during the hospitalization for surgery (up to 30 days)
Secondary outcomes (4)
Perioperative Coefficient of variation of glucose
the standard deviation divided by the average of blood glucose concentration during surgery and first 24 hours after surgery
Measured: During surgery and up to the first 24 hours after surgery
Incidence of Perioperative Coefficient of variation of glucose
the standard deviation of blood glucose concentration during surgery and first 24 hours after surgery
Measured: During surgery and up to the first 24 hours after surgery
Perioperative mean glucose
average of blood glucose concentration during surgery and first 24 hours after surgery
Measured: During surgery and up to the first 24 hours after surgery
Perioperative time-weighted average glucose
time-weighted average of blood glucose concentration during surgery and first 24 hours after surgery
Measured: During surgery and up to the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start23 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease, DiabetesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543449
- Sponsor's protocol ID
- 4-2018-0221
- Status last verified
- Jun 2018
- First submitted
- 20 May 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Preoperative Hemoglobin A1c in Diabetic Patients Underwent Off-Pump Coronary Artery Bypass Surgery: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT03543449
- Acronym / sponsor ID
- 4-2018-0221
- Conditions
- Coronary Artery Disease, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 1 Jun 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.
The aim of this study is to evaluate evaluated the impact of preoperative HbA1c in diabetic patients on perioperative glycemic variability and outcome after off-pump coronary artery bypass (OPCAB).
The medical records of patients who had a preoperative diagnosis of diabetes and underwent OPCAB from 2005 to 2017 will be reviewed. Patients are divided by HbA1c levels (<7.0% or ≥7.0%). Glycemic variability during surgery and up to 24 hours after surgery is assessed by the coefficient of variation. The primary outcome is defined as a composite of postoperative permanent stroke, prolonged ventilation, deep sternal wound infection, renal failure, reoperation, mortality according to the definition of STS (Society of Thoracic Surgery) version 2.81 adult cardiac surgery database. If one or more of the above five morbidity or mortality occur, it is assumed that composite morbidity/mortality had occurred. We compare postoperative complications, mortality and perioperative glycemic variability between patients with HbA1c ≥7.0% and <7.0%, and examined the effects of perioperative glycemic control on postoperative morbidity and mortality (composite morbidity/mortality).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a history of preoperative diabetes mellitus
Key inclusion criteria (2 listed)
- Patients with a history of preoperative diabetes mellitus and with available results of HbA1c test within 3 months before surgery.
- Patients who aged 20 to 89 years
Key exclusion criteria (2 listed)
- Patient who had a history of previous coronary artery bypass surgery
- Patients whose surgery plan changed to cardiopulmonary bypass during surgery.
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 |
|---|---|---|
| Off-Pump Coronary Artery Bypass (OPCAB) surgeryOff-Pump Coronary Artery Bypass (OPCAB) surgery. This study is retrospective study | Other | – |
Primary outcome
Incidence of Permanent stroke
Time frame: during the hospitalization for surgery (up to 30 days)
postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.)
Incidence of Renal failure
Time frame: during the hospitalization for surgery (up to 30 days)
1. Increase in serum creatinine level 3.0 x greater than baseline, or serum creatinine level ≥ 4 mg/dL. The acute rise must be at least 0.5 mg/dl. 2. A new requirement for dialysis postoperatively.
Incidence of Prolonged ventilation
Time frame: during the hospitalization for surgery (up to 30 days)
Prolonged post-operative pulmonary ventilation > 24.0 hours. The hours of postoperative ventilation time include OR exit until extubation, plus any additional hours following reintubation.
Incidence of Deep sternal wound infection
Time frame: during the hospitalization for surgery (up to 30 days)
Deep sternal wound infection or mediastinitis including muscle layer according to CDC definition
Incidence of Re-operation for any reason
Time frame: during the hospitalization for surgery (up to 30 days)
reoperation for bleeding/tamponade, valvular dysfunction, graft occlusion, other cardiac reason, or non-cardiac reason
Operative mortality
Time frame: during the hospitalization for surgery (up to 30 days)
all deaths, regardless of cause
4 secondary outcomes
Perioperative Coefficient of variation of glucose
Time frame: During surgery and up to the first 24 hours after surgery
Incidence of Perioperative Coefficient of variation of glucose
Time frame: During surgery and up to the first 24 hours after surgery
Perioperative mean glucose
Time frame: During surgery and up to the first 24 hours after surgery
Perioperative time-weighted average glucose
Time frame: During surgery and up to the first 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease, Diabetes, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jun 2018. 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 South Korea. 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?
Results are not available in the source record.
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?
Incidence of Permanent stroke (time frame: during the hospitalization for surgery (up to 30 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.