Sarcopenia and Peripheral Artery Disease With Chronic Lim... | NCT07037979

Studies
Sarcopenia and Peripheral Artery Disease With Chronic Limb Threatening Ischemia

NCT07037979

Sponsor

Fudan University

Status

Completed

Last Update Posted

Jun 26, 2025Actual

Enrollment

97Actual

Phase

Not provided

Conditions

Sarcopenia
Peripheral Arterial Disease
Chronic Limb Threatening Ischemia

Interventions

Not applicable- observational study

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Jun 5, 2025

First Submission Date that Met QC Criteria

Jun 24, 2025

First Posted Date

Jun 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2025

Last Update Posted Date

Jun 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patiets with peripheral artery disease			Other: Not applicable- observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not applicable- observational study	Other	non-applicable	patiets with peripheral artery disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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	2023.1.1～2024.12.31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Poor CT quality or incomplete images;
Incomplete clinical data;
In-hospital mortality during Jan.1 2023 and Dec.31 2024.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients of Peripheral Artery Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huadong Hospital, Fudan University		Shanghai		200040	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia
D058729	Peripheral Arterial Disease
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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