Coronary Artery Disease of Significant Bypass GraftNCT06541132
Positive Association of US-FLI With the Severity of CAD
An observational study of Coronary Artery Disease of Significant Bypass Graft and Metabolic Dysfunction-associated Fatty Liver Disease, run by Chongqing Medical University at 1 site in China.
Trial summary
As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease of Significant Bypass Graft, Metabolic Dysfunction-associated Fatty Liver Disease, SYNTAX Score
- What is being tested?
- Observational study without human intervention
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 28 Apr 2025
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All research subjects were from the Second Affiliated Hospital of Chongqing Medical University
Who may be able to join
- Patients older than 18 years old
- Patients underwent ICA due to chest pain, chest tightness or other reasons in our hospital from August 2022 to December 2023 were included in our study
Who cannot join
- Incomplete clinical data
- previous coronary stent implantation
- no abdominal ultrasound examination
- poor ultrasound image quality
- congenital heart disease
- tumor
- thyroid diseases and infectious diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Tingqiu Wang, Bachelor, 17815370539, w857683014@163.com
About this study
Official title: Positive Association Between Ultrasonographic Fatty Liver Indicator and the Severity of Coronary Artery Disease
As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.
Read the detailed description
204 patients who had invasive coronary angiography performed between July 2022 and December 2023 at the cardiology department of the Second Affiliated Hospital of Chongqing Medical University were included in this study. Collect clinical information and abdominal ultrasound images from each patient. Hepatic steatosis which quantified by US-FLI was evaluated by the echo contrast between liver and kidney, posterior attenuation of ultrasound beam, areas of focal sparing, display of hepatic vessels, gallbladder wall and diaphragm. Fatty liver was diagnosed when US-FLI≥2. The severity of CHD was evaluated using the SYNTAX score (SS), and a total of 100 CHD patients were ultimately diagnosed. CHD patients were further divided into the low-risk group (SS ≤ 22) (54 cases) and the medium-high-risk group (SS≥23) (46 cases). Multivariate logistic regression model was used to assess the relationship between US-FLI and SS in patients with MAFLD. The receiver operating characteristic curve was used to determine the accuracy, sensitivity and specificity of US-FLI in predicting SS.
- Conditions
- Coronary Artery Disease of Significant Bypass Graft, Metabolic Dysfunction-associated Fatty Liver Disease, SYNTAX Score, Ultrasonography
- Being tested
- Observational study without human intervention
- Keywords
- Coronary Artery Disease, Metabolic Dysfunction-associated Fatty Liver Disease, SYNTAX score, Ultrasonography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study without human interventionOther
Observational study without human intervention
| Study group | Role | What they receive |
|---|---|---|
| Non-CAD group | non-coronary artery disease group | |
| CAD group | coronary artery disease group Receives: Other: Observational study without human intervention | |
| SS≤22 group | SYNTAX score ≤22 | |
| SS≥23 group | SYNTAX score ≥23 Receives: Other: Observational study without human intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SYNTAX score
The complexity of coronary artery disease (CAD) is a predictor of cardiovascular events in patients with >50 % diameter stenosis as determined by SYNTAX score. The range of US-FLI is 0-8. Fatty liver was diagnosed when US-FLI ≥ 2.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jul 2022
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease of Significant Bypass GraftStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingqiu Wang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541132
- Sponsor's protocol ID
- ChongqingM
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
PubMed 32278004Ballestri S, Nascimbeni F, Baldelli E, Marrazzo A, Romagnoli D, Targher G, Lonardo A. Ultrasonographic fatty liver indicator detects mild steatosis and correlates with metabolic/histological parameters in various liver diseases. Metabolism. 2017 Jul;72:57-65. doi: 10.1016/j.metabol.2017.04.003. Epub 2017 Apr 13.
PubMed 28641784Buckley AJ, Thomas EL, Lessan N, Trovato FM, Trovato GM, Taylor-Robinson SD. Non-alcoholic fatty liver disease: Relationship with cardiovascular risk markers and clinical endpoints. Diabetes Res Clin Pract. 2018 Oct;144:144-152. doi: 10.1016/j.diabres.2018.08.011. Epub 2018 Aug 28.
PubMed 30170074Liu Z, Que S, Xu J, Peng T. Alanine aminotransferase-old biomarker and new concept: a review. Int J Med Sci. 2014 Jun 26;11(9):925-35. doi: 10.7150/ijms.8951. eCollection 2014.
PubMed 25013373
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Association Between Ultrasonographic Fatty Liver Indicator and the Severity of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06541132
- Acronym / sponsor ID
- ChongqingM
- Conditions
- Coronary Artery Disease of Significant Bypass Graft, Metabolic Dysfunction-associated Fatty Liver Disease, SYNTAX Score, Ultrasonography
- Keywords
- Coronary Artery Disease, Metabolic Dysfunction-associated Fatty Liver Disease, SYNTAX score, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2025 (estimated)
- First posted
- 7 Aug 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.
As a multisystem disease, metabolic dysfunction-associated fatty liver disease (MAFLD) is closely linked to the onset and progression of coronary heart disease (CHD). Ultrasonographic fatty liver indicator (US-FLI) is a semi-quantitative tool for evaluating the degree of hepatic steatosis. Our study aims to explore the relationship between US-FLI based on MAFLD and the severity of CHD.
Detailed description
204 patients who had invasive coronary angiography performed between July 2022 and December 2023 at the cardiology department of the Second Affiliated Hospital of Chongqing Medical University were included in this study. Collect clinical information and abdominal ultrasound images from each patient. Hepatic steatosis which quantified by US-FLI was evaluated by the echo contrast between liver and kidney, posterior attenuation of ultrasound beam, areas of focal sparing, display of hepatic vessels, gallbladder wall and diaphragm. Fatty liver was diagnosed when US-FLI≥2. The severity of CHD was evaluated using the SYNTAX score (SS), and a total of 100 CHD patients were ultimately diagnosed. CHD patients were further divided into the low-risk group (SS ≤ 22) (54 cases) and the medium-high-risk group (SS≥23) (46 cases). Multivariate logistic regression model was used to assess the relationship between US-FLI and SS in patients with MAFLD. The receiver operating characteristic curve was used to determine the accuracy, sensitivity and specificity of US-FLI in predicting SS.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-CAD group | – | –non-coronary artery disease group |
| CAD group | – | Other: Observational study without human interventioncoronary artery disease group |
| SS≤22 group | – | –SYNTAX score ≤22 |
| SS≥23 group | – | Other: Observational study without human interventionSYNTAX score ≥23 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All research subjects were from the Second Affiliated Hospital of Chongqing Medical University
Key inclusion criteria (2 listed)
- Patients older than 18 years old
- Patients underwent ICA due to chest pain, chest tightness or other reasons in our hospital from August 2022 to December 2023 were included in our study
Key exclusion criteria (7 listed)
- Incomplete clinical data
- previous coronary stent implantation
- no abdominal ultrasound examination
- poor ultrasound image quality
- congenital heart disease
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 |
|---|---|---|
| Observational study without human interventionObservational study without human intervention | Other | CAD group, SS≥23 group |
Primary outcome
SYNTAX score
Time frame: at baseline
The complexity of coronary artery disease (CAD) is a predictor of cardiovascular events in patients with >50 % diameter stenosis as determined by SYNTAX score. The range of US-FLI is 0-8. Fatty liver was diagnosed when US-FLI ≥ 2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 32278004Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
- Background: PubMed 28641784Ballestri S, Nascimbeni F, Baldelli E, Marrazzo A, Romagnoli D, Targher G, Lonardo A. Ultrasonographic fatty liver indicator detects mild steatosis and correlates with metabolic/histological parameters in various liver diseases. Metabolism. 2017 Jul;72:57-65. doi: 10.1016/j.metabol.2017.04.003. Epub 2017 Apr 13.
- Background: PubMed 30170074Buckley AJ, Thomas EL, Lessan N, Trovato FM, Trovato GM, Taylor-Robinson SD. Non-alcoholic fatty liver disease: Relationship with cardiovascular risk markers and clinical endpoints. Diabetes Res Clin Pract. 2018 Oct;144:144-152. doi: 10.1016/j.diabres.2018.08.011. Epub 2018 Aug 28.
- Background: PubMed 25013373Liu Z, Que S, Xu J, Peng T. Alanine aminotransferase-old biomarker and new concept: a review. Int J Med Sci. 2014 Jun 26;11(9):925-35. doi: 10.7150/ijms.8951. eCollection 2014.
- 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 of Significant Bypass Graft and Metabolic Dysfunction-associated Fatty Liver Disease, run by Chongqing Medical University at 1 site in China.
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 7 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 Aug 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 China. 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 Tingqiu Wang (+8617815370539, w857683014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SYNTAX score (time frame: at 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 NCT06541132, which also lists 4 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 21 Aug 2024.