POP-CLI: Peri-operative Foot CT Perfusion in CLI Patients

Sponsor

Fudan University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05575778

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Critical Limb Ischemia	Diagnostic Test: computed tomographic perfusion

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

All-cause deah [12months]
All-cause deah during the follow-up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hua Dong Hospital Affiliated to Fu Dan University	Shanghai		China

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator: Wan Zhang, PH.D., Huadong Hospital affiliated to Fudan University, Shanghai, China, 200040

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhijun Bao, Director, Fudan University

ClinicalTrials.gov Identifier:

NCT05575778

Other Study ID Numbers:

2022KW

First Posted:

Oct 12, 2022

Last Update Posted:

Oct 12, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ischemia

Study Results

No Results Posted as of Oct 12, 2022