Peri-operative Foot CT Perfusion in CLI Patients (POP-CLI)

October 8, 2022 updated by: Zhijun Bao, Fudan University

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Hua Dong Hospital Affiliated to Fu Dan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-operative computed tomographic perfusion parameters
Time Frame: 18months
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
Time Frame: 18months
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
Time Frame: 18months
Alteration between post- (three days ater revascularization) and pre-operative (three days before revascularization) computed tomographic perfusion parameters
18months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse limb events
Time Frame: 12months
Major adverse limb events included major amputation or acute limb ishchemia for vasular causes.
12months
Major adverse cardiovascular events
Time Frame: 12months
Major adverse cardiovascular events included myocardial infarction, ischemic stroke, or death from cadiovascular causes.
12months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause deah
Time Frame: 12months
All-cause deah during the follow-up period
12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 8, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 8, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022KW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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