Critical Limb Ischemia
Conditions
Brief summary
To investigate the clinical value of quantitative analysis of peri-operative foot supply through CT perfusion in patients with critical limb ischemia
Interventions
DIAGNOSTIC_TESTcomputed tomographic perfusion
The recruited patients would complete both pre- and post-operative computed tomographic perfusion
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWan Zhang, PH.D.
Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040
Outcome results
None listed