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To establish a prospective cohort study and prognostic model of lower limb ischemia and muscle volume based on clinical multi-dimensional database

To establish a prospective cohort study and prognostic model of lower limb ischemia and muscle volume based on clinical multi-dimensional database

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093501
Enrollment
Unknown
Registered
2024-12-06
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower limb ischemia

Interventions

Training set:None
Validation set:None

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: In the first part of the study (multicenter retrospective): the medical records and CT or CTA results of patients with lower limb ischemia who had completed the clinical routine 6 months of follow-up before June 2024 were retrospectively collected by each center, and no information that could identify the subjects was recorded. Inclusion criteria: age >=45 years old, male or female; Patients with chronic lower limb ischemia who had undergone interventional procedures and completed routine clinical follow-up for 6 months; Patients with preoperative CT or CTA results of the lower extremities. The second part was a single-center prospective study: This part of the study was only conducted in Beijing Hospital and prospectively collected the preoperative and postoperative medical records of patients with chronic lower limb ischemia who had undergone interventional therapy. Inclusion criteria: age >=45 years old, male or female; Patients with Rutherford stage 3-5 chronic lower limb ischemia who planned to undergo interventional therapy; Patients with preoperative CT or CTA results of the lower extremities.

Exclusion criteria

Exclusion criteria: Part I Study (Multicenter retrospective): Each center retrospectively collected the medical records and CT or CTA results of patients with lower limb ischemia who had completed the clinical routine 6 months of follow-up before June 2024, and did not record any information that could identify the subjects. Exclusion criteria: patients with previous lower limb amputation; Acute lower limb ischemia; The image quality of CTA is poor, which affects the interpretation of the observation area. Part II Study (Single-center prospective study) This part of the study was only conducted in Beijing Hospital, and the preoperative and postoperative medical records of patients with chronic lower limb ischemia who had undergone interventional therapy were prospectively collected. Exclusion criteria: acute lower limb ischemia; Patients with previous lower limb amputation; Patients undergoing open bypass surgery; Contraindication of contrast media; Patients with hepatic and renal insufficiency.

Design outcomes

Primary

MeasureTime frame
CT body composition analysis;Blood routine examination;Blood biochemistry;Lower extremity vascular stenosis;Death event;Cardiovascular and cerebrovascular events;Blood coagulation test;Imaging data such as muscle volume and calcification on CTA or CT impact;The imaging feature omics of CTA, such as Gaussian filter, etc;Amputation;Reintervention;Amputation-free survival;Duration of surgery;Surgical details included surgical site, puncture method, etc;

Countries

China

Contacts

Public ContactYongpeng Diao

Department of Vascular Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences

sunheartdyp@163.com+86 135 8161 1275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026