Coronary Artery DiseaseNCT05449509
Abdominal Aortic Aneurysm Screening Before Coronary Artery Bypass Surgery
An observational study of Coronary Artery Disease and Abdominal Aortic Aneurysm, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery disease (CAD) and abdominal aortic aneurysm (AAA) are two separate entities with common risk factors such as hypertension, advanced age, male sex. Atherosclerosis plays an important role in the etiology of both diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Abdominal Aortic Aneurysm
- What is being tested?
- Abdominal aortic Duplex ultrasound
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 30 Aug 2023
- 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: Consecutive adult patients undergoing elective CABG in the Department of Cardiovascular Surgery in Basaksehir Cam Sakura City Hospital
Who may be able to join
- Undergoing coronary artery bypass graft surgery
- Age >18 years
Who cannot join
- Age <18 years
- Pregnancy
- Breastfeeding
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam ve Sakura City Hospital
Istanbul
Kamile Ozeren Topcu, MD, 902169096000
About this study
Official title: Association of SYNTAX Score With Abdominal Aortic Aneurysm in Patients Undergoing Coronary Artery Bypass Graft Surgery: Who Should be Screened?
Coronary artery disease (CAD) and abdominal aortic aneurysm (AAA) are two separate entities with common risk factors such as hypertension, advanced age, male sex. Atherosclerosis plays an important role in the etiology of both diseases. It has been reported that AAA is more prevalent in patients undergoing coronary artery bypass grafting (CABG). Despite all the evidence, current guidelines do not recommend routine screening for AAA before CABG. Syntax score shows anatomical significance of CAD and is associated with the degree of atherosclerotic load. The investigators aim to investigate if there were any differences regarding AAA prevalence in high-SYNTAX patients versus intermediate/low-SYNTAX patients.
- Conditions
- Coronary Artery Disease, Abdominal Aortic Aneurysm
- Being tested
- Abdominal aortic Duplex ultrasound
- Medical subject headings
- Coronary Artery Disease, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal aortic Duplex ultrasoundDiagnostic test
All patients will undergo bedside Duplex ultrasound in order to measure infrarenal abdominal aortic diameter.
| Study group | Role | What they receive |
|---|---|---|
| High-SYNTAX score patients | Not described Receives: Diagnostic Test: Abdominal aortic Duplex ultrasound | |
| Intermediate/low-SYNTAX score patients | Not described Receives: Diagnostic Test: Abdominal aortic Duplex ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infrarenal abdominal aortic diameter
Infrarenal abdominal aortic diameter measured by bedside Duplex ultrasound by the principal investigator, Dr. Ozeren-Topcu
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kamile Özeren Topçu, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449509
- Sponsor's protocol ID
- KAEK/2022.02.43
- Status last verified
- Feb 2023
- First submitted
- 2 Jul 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergersen L, Kiernan MS, McFarlane G, Case TD, Ricci MA. Prevalence of abdominal aortic aneurysms in patients undergoing coronary artery bypass. Ann Vasc Surg. 1998 Mar;12(2):101-5. doi: 10.1007/s100169900124.
PubMed 9514225Yammine M, Itagaki S, Pawale A, Toyoda N, Reddy RC. SYNTAX score may predict the severity of atherosclerosis of the ascending aorta. J Thorac Dis. 2017 Oct;9(10):3859-3865. doi: 10.21037/jtd.2017.09.17.
PubMed 29268395
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of SYNTAX Score With Abdominal Aortic Aneurysm in Patients Undergoing Coronary Artery Bypass Graft Surgery: Who Should be Screened?
- ClinicalTrials.gov ID
- NCT05449509
- Acronym / sponsor ID
- KAEK/2022.02.43
- Conditions
- Coronary Artery Disease, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 8 Jul 2022 (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.
Coronary artery disease (CAD) and abdominal aortic aneurysm (AAA) are two separate entities with common risk factors such as hypertension, advanced age, male sex. Atherosclerosis plays an important role in the etiology of both diseases. It has been reported that AAA is more prevalent in patients undergoing coronary artery bypass grafting (CABG). Despite all the evidence, current guidelines do not recommend routine screening for AAA before CABG. Syntax score shows anatomical significance of CAD and is associated with the degree of atherosclerotic load. The investigators aim to investigate if there were any differences regarding AAA prevalence in high-SYNTAX patients versus intermediate/low-SYNTAX patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-SYNTAX score patients | – | Diagnostic Test: Abdominal aortic Duplex ultrasound |
| Intermediate/low-SYNTAX score patients | – | Diagnostic Test: Abdominal aortic Duplex ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients undergoing elective CABG in the Department of Cardiovascular Surgery in Basaksehir Cam Sakura City Hospital
Key inclusion criteria (2 listed)
- Undergoing coronary artery bypass graft surgery
- Age >18 years
Key exclusion criteria (4 listed)
- Age <18 years
- Pregnancy
- Breastfeeding
- Emergency 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 |
|---|---|---|
| Abdominal aortic Duplex ultrasoundAll patients will undergo bedside Duplex ultrasound in order to measure infrarenal abdominal aortic diameter. | Diagnostic test | High-SYNTAX score patients, Intermediate/low-SYNTAX score patients |
Primary outcome
Infrarenal abdominal aortic diameter
Time frame: Baseline
Infrarenal abdominal aortic diameter measured by bedside Duplex ultrasound by the principal investigator, Dr. Ozeren-Topcu
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 9514225Bergersen L, Kiernan MS, McFarlane G, Case TD, Ricci MA. Prevalence of abdominal aortic aneurysms in patients undergoing coronary artery bypass. Ann Vasc Surg. 1998 Mar;12(2):101-5. doi: 10.1007/s100169900124.
- Background: PubMed 29268395Yammine M, Itagaki S, Pawale A, Toyoda N, Reddy RC. SYNTAX score may predict the severity of atherosclerosis of the ascending aorta. J Thorac Dis. 2017 Oct;9(10):3859-3865. doi: 10.21037/jtd.2017.09.17.
- 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 Disease and Abdominal Aortic Aneurysm, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 4 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 14 Feb 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 Turkey (Türkiye). 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?
Contact Kamile Ozeren-Topcu, MD (902129096000, kammileozeren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infrarenal abdominal aortic diameter (time frame: Baseline). 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 NCT05449509, which also lists 2 linked publications.
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 14 Feb 2023.