Peri-operative Foot CT Perfusion in CLI Patients

Fudan University90 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Critical Limb Ischemia

Interventions

computed tomographic perfusionDIAGNOSTIC_TEST

The recruited patients would complete both pre- and post-operative computed tomographic perfusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hua Dong Hospital Affiliated to Fu Dan University

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 18months

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.

Time frame: 18months

Alteration of computed tomographic perfusion parameters

Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters

Time frame: 18months

Secondary Outcomes

Major adverse limb events

Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.

Time frame: 12months

Major adverse cardiovascular events

Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.

Time frame: 12months

Data from ClinicalTrials.gov

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