Peri-operative Foot CT Perfusion in CLI Patients

Critical Limb Ischemia Clinical Trial

— POP-CLI  

Official title:

The Clinical Value of Quantitative Analysis of Peri-operative Foot Supply Through CT Perfusion in Patients With Critical Limb Ischemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05575778
• Other study ID #: 2022KW
• Status: Active, not recruiting
• Start date: October 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Diagnostic Test:
• computed tomographic perfusion
The recruited patients would complete both pre- and post-operative computed tomographic perfusion

Locations

Country	Name	City	State
China	Hua Dong Hospital Affiliated to Fu Dan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause deah	All-cause deah during the follow-up period	12months
Primary	Pre-operative computed tomographic perfusion parameters	Pre-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days before revascularization.	18months
Primary	Post-operative computed tomographic perfusion parameters	Post-operative computed tomographic perfusion parameters, including peak intensity, time to peak, and etc, which would be obtained three days ater revascularization.	18months
Primary	Alteration of computed tomographic perfusion parameters	Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters	18months
Secondary	Major adverse limb events	Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.	12months
Secondary	Major adverse cardiovascular events	Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.	12months