Peri-operative Foot CT Perfusion in CLI Patients

Active, not recruiting

• Conditions: Critical Limb Ischemia

• Registration Number: NCT05575778
• Lead Sponsor: Fudan University

Brief Summary

To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-08
• Last Update Submitted: 2022-10-08
• Study First Posted: 2022-10-12
• Last Update Posted: 2022-10-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 18 to 80 years old;
• CLI patients with Fontaine grade III-IV or Rutherford grade 4-6 and underwent a successful revascularization;
• Patients completed both pre- and post-operative CTP workups;
• Patients signed the informed consent form and be able to complete the clinical follow-up for 12 months.

Read More

Exclusion Criteria

• Patients has participated in other clinical studies;
• Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate<60 ml/min)
• Any allergic constitution;
• Pregnancy and childbirth;
• Life expectancy<12 months.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-operative computed tomographic perfusion parameters	18months	Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization.
Post-operative computed tomographic perfusion parameters	18months	Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization.
Alteration of computed tomographic perfusion parameters	18months	Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters

Secondary Outcome Measures

Name	Time	Method
Major adverse limb events	12months	Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.
Major adverse cardiovascular events	12months	Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.

Trial Locations

Locations (1)

Hua Dong Hospital Affiliated to Fu Dan University; 🇨🇳 Shanghai, China