Coronary Artery Bypass, Off-PumpNCT06399627
Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
An observational study of Coronary Artery Bypass, Off-Pump and Iron Deficiencies, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. Read more about this study
- Who is it for?
- Ages 29 to 85 years
- Conditions the study is for
- Coronary Artery Bypass, Off-Pump, Iron Deficiencies
- How many people
- 433 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2016to 31 May 2024
- 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 29 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-anemic patients who underwent off pump coronary artery bypass surgery
Who may be able to join
- Patients who received off pump coronary artery bypass surgery (OPCAB) between 2016.11.01-2023.05.31
Who cannot join
- preoperative anemia (male Hb <13g/dL, female Hb<12g/dL)
- emergency surgery
- redo-off pump coronary artery bypass surgery
- minimally invasive coronary artery bypass surgery
- OPCAB in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta)
- intraoperative on pump conversion
Show all 9Show fewer
- lack of sufficient preoperative data (ferritin, transferrin saturation, C-reactive protein) to determine iron status
- administration of intravenous iron within 4 weeks or parenteral iron of more than 2 weeks prior to surgery
- enrollemnt in other clinical studies
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health system, Severance Hospital
Seoul, 03722
seohee Ko, 82-10-9345-6520, shk0207@yuhs.ac
About this study
This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. These two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes.
The primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. Occurrence of any one of these outcomes counted as primary end point met. Secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Iron replete | Patient who did not meet the criteria for iron deficiency (see below) | |
| Iron deficient | patients with preoperative iron profile of either of the following were defined as iron deficient: 1. serum ferritin <100mcg/L 2. 100mcg/L < serum ferritin <300mcg/L and * transferrin saturation < 20% or * C reactive protein ≥ 5mg/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Measured: from the end of surgery until patient discharge (assessed up to day 60)
Number of participants with acute kidney injury
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Measured: until 7 days after surgery
Number of participants with post operative myocardial infarction
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Measured: until 48 hours post-surgery
Secondary outcomes (1)
Post discharge hemoglobin
Data of hemoglobin levels after discharge until 1 year after surgery was collected to evaluate hemoglobin recovery to preoperative baseline levels.
Measured: Until 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Nov 2016
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass, Off-PumpStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 433 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399627
- Sponsor's protocol ID
- 4-2022-1112
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-anemic Iron Deficiency on Outcome Following Off-pump Coronary Revascularization
- ClinicalTrials.gov ID
- NCT06399627
- Acronym / sponsor ID
- 4-2022-1112
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 433 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 6 May 2024 (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.
This is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11~2023.05. From this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. These two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes.
The primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. Occurrence of any one of these outcomes counted as primary end point met. Secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron replete | – | –Patient who did not meet the criteria for iron deficiency (see below) |
| Iron deficient | – | –patients with preoperative iron profile of either of the following were defined as iron deficient: 1. serum ferritin <100mcg/L 2. 100mcg/L < serum ferritin <300mcg/L and * transferrin saturation < 20% or * C reactive protein ≥ 5mg/L |
Who may qualify
- Ages
- 29 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-anemic patients who underwent off pump coronary artery bypass surgery
Key inclusion criteria (1 listed)
- Patients who received off pump coronary artery bypass surgery (OPCAB) between 2016.11.01-2023.05.31
Key exclusion criteria (9 listed)
- preoperative anemia (male Hb <13g/dL, female Hb<12g/dL)
- emergency surgery
- redo-off pump coronary artery bypass surgery
- minimally invasive coronary artery bypass surgery
- OPCAB in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium
Time frame: from the end of surgery until patient discharge (assessed up to day 60)
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Number of participants with acute kidney injury
Time frame: until 7 days after surgery
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
Number of participants with post operative myocardial infarction
Time frame: until 48 hours post-surgery
This outcome is a composite of the following: in hospital mortality, acute kidney injury (AKI), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. The occurrence of any one of these was regarded as primary end point met.
1 secondary outcome
Post discharge hemoglobin
Time frame: Until 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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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.
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 Bypass, Off-Pump and Iron Deficiencies, 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 1 inclusion and 9 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 6 May 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with in hospital mortality, stroke, deep sternal infection, hemostatic reoperation, delirium (time frame: from the end of surgery until patient discharge (assessed up to day 60)). The study lists 3 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 6 May 2024.