Peri-operative Foot CT Perfusion in CLI Patients

NCT05575778 | Unknown

• 1 other identifier: 2022KW
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Major adverse limb events

  12months

• Major adverse cardiovascular events

  12months

Other Outcomes (1)

• All-cause deah

  12months

Interventions

computed tomographic perfusion DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with critical limb ischemia, who completed both pre- and post-operative CTP workups

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Hua Dong Hospital Affiliated to Fu Dan University

Shanghai, China

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Wan Zhang, PH.D.

  Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: October 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)