Myocardial Injury After Non-cardiac SurgeryNCT06088641
Preoperative BNP and MINS in AAA Open Repair
An observational study of Myocardial Injury After Non-cardiac Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The aim of this study was to investigate whether preoperative B-type natriuretic peptides serves as an independent predictor of myocardial injury after non-cardiac surgery (MINS) in abdominal aortic aneurysm open repair. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Myocardial Injury After Non-cardiac Surgery
- What is being tested?
- preoperative BNP value
- How many people
- 198 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 6 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent AAA open repair
Who may be able to join
- patients who underwent open repair with AAA from September 2010 to October 2021
Who cannot join
- Ruptured AAA
- Traumatic aortic injury
- Absence of troponin-T value within 30 days of surgery
- Diagnosis of elevation of troponin-T due to non-ischemic cause (ex: sepsis, pulmonary embolism, atrial fibrillation, cardioversion, etc.)
- Insufficient medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Impact of Preoperative B-type Natriuretic Peptide for Predicting Myocardial Injury After Non-cardiac Surgery in Patients Who Underwent Open Repair for Abdominal Aortic Aneurysm: a Retrospective Study
The aim of this study was to investigate whether preoperative B-type natriuretic peptides serves as an independent predictor of myocardial injury after non-cardiac surgery (MINS) in abdominal aortic aneurysm open repair.
Read the detailed description
The incidence of MINS was compared between the lower BNP and higher BNP groups, and a stepwise logistic regression analysis was performed to evaluate the predictors for MINS.
- Being tested
- preoperative BNP value
- Keywords
- AAA, MINS, BNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative BNP valueDiagnostic test
preoperative BNP value
| Study group | Role | What they receive |
|---|---|---|
| Lower BNP | preoperative Lower BNP Receives: Diagnostic Test: preoperative BNP value | |
| Higher BNP | preoperative higher BNP Receives: Diagnostic Test: preoperative BNP value |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINS
MINS is defined as an elevated Troponin-T within 30 days of surgery. The patients were divided into two groups based on their preoperative BNP levels, and the incidence of MINS was compared between the two groups.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jan 2022
- Primary completion30 Mar 2023
- Study completion6 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Injury After Non-cardiac 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Yeon Ham, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088641
- Sponsor's protocol ID
- 3-2023-0187
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Preoperative B-type Natriuretic Peptide for Predicting Myocardial Injury After Non-cardiac Surgery in Patients Who Underwent Open Repair for Abdominal Aortic Aneurysm: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06088641
- Acronym / sponsor ID
- 3-2023-0187
- Keywords
- AAA, MINS, BNP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 6 Jul 2024 (estimated)
- First posted
- 18 Oct 2023 (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 was to investigate whether preoperative B-type natriuretic peptides serves as an independent predictor of myocardial injury after non-cardiac surgery (MINS) in abdominal aortic aneurysm open repair.
Detailed description
The incidence of MINS was compared between the lower BNP and higher BNP groups, and a stepwise logistic regression analysis was performed to evaluate the predictors for MINS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower BNP | – | Diagnostic Test: preoperative BNP valuepreoperative Lower BNP |
| Higher BNP | – | Diagnostic Test: preoperative BNP valuepreoperative higher BNP |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent AAA open repair
Key inclusion criteria (1 listed)
- patients who underwent open repair with AAA from September 2010 to October 2021
Key exclusion criteria (5 listed)
- Ruptured AAA
- Traumatic aortic injury
- Absence of troponin-T value within 30 days of surgery
- Diagnosis of elevation of troponin-T due to non-ischemic cause (ex: sepsis, pulmonary embolism, atrial fibrillation, cardioversion, etc.)
- Insufficient medical records
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 |
|---|---|---|
| preoperative BNP valuepreoperative BNP value | Diagnostic test | Higher BNP, Lower BNP |
Primary outcome
MINS
Time frame: 30 days after surgery
MINS is defined as an elevated Troponin-T within 30 days of surgery. The patients were divided into two groups based on their preoperative BNP levels, and the incidence of MINS was compared between the two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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 Myocardial Injury After Non-cardiac 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 5 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 18 Nov 2023. 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?
MINS (time frame: 30 days 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 18 Nov 2023.