SarcopeniaSACNCT07037979
Sarcopenia and Peripheral Artery Disease With Chronic Limb Threatening Ischemia
An observational study of Sarcopenia and Peripheral Arterial Disease, run by Fudan University at 1 site in China.
Trial summary
To evaluate the correlation of Sarcopenia Parameters and Peripheral Artery Disease with chronic limb threatening ischaemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, Peripheral Arterial Disease, Chronic Limb Threatening Ischemia
- What is being tested?
- Not applicable- observational study
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of Peripheral Artery Disease
Who may be able to join
- Patients of Peripheral Artery Disease, including intermittent claudication and Chronic Limb Threatening Ischemia;
- Patients with Rutherford grade 2-6 between Jan.1 2023 and Dec.31 2024;
- Patients at age 18-80;
- Patients underwent an in-hospital routine enhanced whole abdomen to lower extremities CT scan;
- Patients able to complete the clinical follow-up for 3 months.
Who cannot join
- Poor CT quality or incomplete images;
- Incomplete clinical data;
- In-hospital mortality during Jan.1 2023 and Dec.31 2024.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Sarcopenia and Peripheral Artery Disease With Chronic Limb Threatening Ischemia
To evaluate the correlation of Sarcopenia Parameters and Peripheral Artery Disease with chronic limb threatening ischaemia.
Read the detailed description
Prior researches indicated a relatively high prevalence of sarcopenia among patients of Peripheral Artery Disease. However, the relationship between sarcopenia and progression of Peripheral Artery Disease with chronic limb threatening ischaemia remained poorly understood. Thus, this cohort study aimed to evaluate the correlation of Sarcopenia Parameters, such as psoas muscle area (PMA) and total abdominal muscle area (TAMA) at the L3 vertebral level, measured by computed tomography (CT), and progression of Peripheral Artery Disease with chronic limb threatening ischaemia.
- Being tested
- Not applicable- observational study
- Medical subject headings
- Sarcopenia, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
non-applicable
| Study group | Role | What they receive |
|---|---|---|
| patiets with peripheral artery disease | Not described Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
psoas muscle area (PMA) [measured by computed tomography (CT)]
psoas muscle area (PMA) (square centimeters) was regarded as a kind of typical sarcopenia parameters, measured by computed tomography (CT) at the L3 vertebral level
Measured: 2023.1.1~2024.12.31
total abdominal muscle area (TAMA) measured by computed tomography (CT)
total abdominal muscle area (TAMA) (square centimeters) was regarded as a kind of typical sarcopenia parameters, measured by computed tomography (CT) at the L3 vertebral level
Measured: 2023.1.1~2024.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037979
- Sponsor's protocol ID
- 2025ZW02
- Acronym
- SAC
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Sarcopenia and Peripheral Artery Disease With Chronic Limb Threatening Ischemia
- ClinicalTrials.gov ID
- NCT07037979
- Acronym / sponsor ID
- SAC / 2025ZW02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jun 2025 (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.
To evaluate the correlation of Sarcopenia Parameters and Peripheral Artery Disease with chronic limb threatening ischaemia.
Detailed description
Prior researches indicated a relatively high prevalence of sarcopenia among patients of Peripheral Artery Disease. However, the relationship between sarcopenia and progression of Peripheral Artery Disease with chronic limb threatening ischaemia remained poorly understood. Thus, this cohort study aimed to evaluate the correlation of Sarcopenia Parameters, such as psoas muscle area (PMA) and total abdominal muscle area (TAMA) at the L3 vertebral level, measured by computed tomography (CT), and progression of Peripheral Artery Disease with chronic limb threatening ischaemia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patiets with peripheral artery disease | – | Other: Not applicable- observational study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of Peripheral Artery Disease
Key inclusion criteria (5 listed)
- Patients of Peripheral Artery Disease, including intermittent claudication and Chronic Limb Threatening Ischemia;
- Patients with Rutherford grade 2-6 between Jan.1 2023 and Dec.31 2024;
- Patients at age 18-80;
- Patients underwent an in-hospital routine enhanced whole abdomen to lower extremities CT scan;
- Patients able to complete the clinical follow-up for 3 months.
Key exclusion criteria (3 listed)
- Poor CT quality or incomplete images;
- Incomplete clinical data;
- In-hospital mortality during Jan.1 2023 and Dec.31 2024.
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 |
|---|---|---|
| Not applicable- observational studynon-applicable | Other | patiets with peripheral artery disease |
Primary outcome
psoas muscle area (PMA) [measured by computed tomography (CT)]
Time frame: 2023.1.1~2024.12.31
psoas muscle area (PMA) (square centimeters) was regarded as a kind of typical sarcopenia parameters, measured by computed tomography (CT) at the L3 vertebral level
total abdominal muscle area (TAMA) measured by computed tomography (CT)
Time frame: 2023.1.1~2024.12.31
total abdominal muscle area (TAMA) (square centimeters) was regarded as a kind of typical sarcopenia parameters, measured by computed tomography (CT) at the L3 vertebral level
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 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 Sarcopenia and Peripheral Arterial Disease, run by Fudan 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 3 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 26 Jun 2025. 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?
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?
psoas muscle area (PMA) [measured by computed tomography (CT)] (time frame: 2023.1.1~2024.12.31). The study lists 2 primary outcomes in all. 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 26 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.