Patients Undergoing Off-pump Coronary Artery by Pass SurgeryNCT06435416
Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
An observational study of Patients Undergoing Off-pump Coronary Artery by Pass Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Off-pump Coronary Artery by Pass Surgery
- How many people
- 983 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2023to 10 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing off-pump coronary artery bypass surgery
Who may be able to join
- Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery
Who cannot join
- Patients without PNI value between 1 and 3 days after surgery
- Patients without PNI value between 20 and 60 days after surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.
- Being tested
- No intervention
- Keywords
- Prognostic Nutritional Index (PNI), Off-pump coronary artery bypass (OPCAB),, Coronary artery bypass graft surgery (CABG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| PNI trajectory group 1 | Not described Receives: Other: No intervention | |
| PNI trajectory group 2 | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year mortality
1 year after surgery
Measured: one-year mortality after surgery
Secondary outcomes (1)
Overall mortality
Overall mortality after surgery
Measured: Up to the last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start12 Jul 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Off-pump Coronary Artery by Pass SurgeryStudies of the same condition, open and under way.
- 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
- 983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Il Bae, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435416
- Sponsor's protocol ID
- 3-2023-0184
- Status last verified
- Oct 2024
- First submitted
- 24 May 2024
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT06435416
- Acronym / sponsor ID
- 3-2023-0184
- Keywords
- Prognostic Nutritional Index (PNI), Off-pump coronary artery bypass (OPCAB),, Coronary artery bypass graft surgery (CABG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 30 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 study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNI trajectory group 1 | – | Other: No intervention |
| PNI trajectory group 2 | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing off-pump coronary artery bypass surgery
Key inclusion criteria (1 listed)
- Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery
Key exclusion criteria (2 listed)
- Patients without PNI value between 1 and 3 days after surgery
- Patients without PNI value between 20 and 60 days after 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 |
|---|---|---|
| No interventionNo intervention | Other | PNI trajectory group 1, PNI trajectory group 2 |
Primary outcome
one-year mortality
Time frame: one-year mortality after surgery
1 year after surgery
1 secondary outcome
Overall mortality
Time frame: Up to the last follow-up
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 28 Oct 2024.
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 Patients Undergoing Off-pump Coronary Artery by Pass Surgery, run by Gangnam Severance Hospital 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 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: finished, as of the sponsor's last update on 28 Oct 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?
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?
one-year mortality (time frame: one-year mortality after surgery). 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 28 Oct 2024.