GoutNCT07784049
The Correlation Between Sodium Urate (MSU) Deposition and Coronary Atherosclerosis in Patients With Foot Gout
An observational study of Gout and Coronary Atheroma, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This observational study aims to evaluate the association between sodium urate deposition volume and coronary atherosclerotic plaques in patients with foot gout using dual-energy CT (DECT) and coronary CTA. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gout, Coronary Atheroma
- What is being tested?
- DECT;CCTA
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with podagra who have high-risk factors for cardiovascular disease
Who may be able to join
- Aged ≥18 years, male or female
- Clinically diagnosed with podagra
- Having high-risk factors for cardiovascular disease
- Complete clinical data available
- Patients and their family members are informed, consent and have signed the informed consent form
Who cannot join
- Women who are preparing for pregnancy, pregnant or breastfeeding
- Male and female subjects of reproductive age who are unable to take effective contraceptive measures
- Patients who cannot or are unable to undergo CTA scans
- Patients with severe heart diseases such as severe heart failure, severe heart valve disease and cardiomyopathy
- Severe hemodynamic instability
- Any other reason making subjects unsuitable to participate in the study, including subjects who are unable or unwilling to comply with the requirements of the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
Official title: Affiliated Hospital of Qingdao University
This observational study aims to evaluate the association between sodium urate deposition volume and coronary atherosclerotic plaques in patients with foot gout using dual-energy CT (DECT) and coronary CTA. This study will explore imaging-based evidence for the progression and risk prediction of adverse cardiovascular events in patients with gout.
Read the detailed description
Gout is a common form of inflammatory arthritis characterized by the deposition of monosodium urate crystals in joints and other tissues. This condition triggers an acute inflammatory response; over time, it can increase the incidence and disability associated with chronic gout. Beyond the musculoskeletal system, gout is also linked to an elevated risk of cardiovascular diseases (e.g., coronary artery disease). Chronic inflammation and endothelial dysfunction are the primary mechanisms underlying this association. In recent years, dual-energy computed tomography (DECT) has enabled the direct detection of MSU deposits in the ankle joint and coronary artery walls, which may serve as one of the driving factors for plaque inflammation and rupture. DECT utilizes distinct energy absorption spectra to differentiate MSU deposits from other substances, providing an non-invasive method for assessing the extent of MSU crystal deposition. It has been demonstrated that DECT can be accurately employed to identify MSU deposits within larger anatomical structures-such as urate crystals in peripheral joints-as well as to detect MSU within coronary artery plaques. In conclusion, monitoring the relationship between gout burden and the severity of atherosclerosis in patients with podagra can serve as an imaging-based reference for predicting the risk of cardiovascular adverse events in these patients.
- Conditions
- Gout, Coronary Atheroma
- Being tested
- DECT;CCTA
- Medical subject headings
- Gout, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECT;CCTADiagnostic test
Perform DECT and CCTA examinations on the patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of sodium urate deposition and coronary artery plaque volume
Measurement of sodium urate deposition volume and coronary artery plaque volume in patients with foot gout.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784049
- Sponsor's protocol ID
- QYFYEC2026-30
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affiliated Hospital of Qingdao University
- ClinicalTrials.gov ID
- NCT07784049
- Acronym / sponsor ID
- QYFYEC2026-30
- Conditions
- Gout, Coronary Atheroma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 25 Aug 2026 (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 observational study aims to evaluate the association between sodium urate deposition volume and coronary atherosclerotic plaques in patients with foot gout using dual-energy CT (DECT) and coronary CTA. This study will explore imaging-based evidence for the progression and risk prediction of adverse cardiovascular events in patients with gout.
Detailed description
Gout is a common form of inflammatory arthritis characterized by the deposition of monosodium urate crystals in joints and other tissues. This condition triggers an acute inflammatory response; over time, it can increase the incidence and disability associated with chronic gout. Beyond the musculoskeletal system, gout is also linked to an elevated risk of cardiovascular diseases (e.g., coronary artery disease). Chronic inflammation and endothelial dysfunction are the primary mechanisms underlying this association. In recent years, dual-energy computed tomography (DECT) has enabled the direct detection of MSU deposits in the ankle joint and coronary artery walls, which may serve as one of the driving factors for plaque inflammation and rupture. DECT utilizes distinct energy absorption spectra to differentiate MSU deposits from other substances, providing an non-invasive method for assessing the extent of MSU crystal deposition. It has been demonstrated that DECT can be accurately employed to identify MSU deposits within larger anatomical structures-such as urate crystals in peripheral joints-as well as to detect MSU within coronary artery plaques. In conclusion, monitoring the relationship between gout burden and the severity of atherosclerosis in patients with podagra can serve as an imaging-based reference for predicting the risk of cardiovascular adverse events in these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with podagra who have high-risk factors for cardiovascular disease
Key inclusion criteria (5 listed)
- Aged ≥18 years, male or female
- Clinically diagnosed with podagra
- Having high-risk factors for cardiovascular disease
- Complete clinical data available
- Patients and their family members are informed, consent and have signed the informed consent form
Key exclusion criteria (6 listed)
- Women who are preparing for pregnancy, pregnant or breastfeeding
- Male and female subjects of reproductive age who are unable to take effective contraceptive measures
- Patients who cannot or are unable to undergo CTA scans
- Patients with severe heart diseases such as severe heart failure, severe heart valve disease and cardiomyopathy
- Severe hemodynamic instability
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 |
|---|---|---|
| DECT;CCTAPerform DECT and CCTA examinations on the patient | Diagnostic test | – |
Primary outcome
Volume of sodium urate deposition and coronary artery plaque volume
Time frame: baseline
Measurement of sodium urate deposition volume and coronary artery plaque volume in patients with foot gout.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- 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.
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 Gout and Coronary Atheroma, run by The Affiliated Hospital of Qingdao 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Volume of sodium urate deposition and coronary artery plaque volume (time frame: baseline). 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 25 Aug 2026.