Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease

We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease; Perfusion
• Intervention / Treatment: Diagnostic test: DCE MRI

• Study Type: Observational
• Enrollment (Estimated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with peripheral artery disease, who had a successful endovascular treatment and completed both pre- and post-operative MRI workups

Description

Inclusion Criteria:

• 18 to 80 years old;
• PAD patients with Fontaine grade II-IV or Rutherford grade 2-6 and underwent a successful revascularization;
• Patients completed both pre- and post-operative MRI workups;
• Patients signed the informed consent form and be able to complete the clinical follow-up for 1 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PAD group; patients of peripheral artery disease who underwent endovascular treatment	Diagnostic test: DCE MRI; the recruited patients should complete pre- and post-operative DCE MRI workshops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative perfusion parameters	preoperative perfusion parameters by dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI)	Between Aug.1 2024 and OCT.31 2024

Secondary Outcome Measures

Outcome Measure	Time Frame
ankle brachial index	Between Aug.1 2024 and OCT.31 2024
clinical success	Between Aug.1 2024 and NOV.30 2024
survival	Between Aug.1 2024 and NOV.30 2024

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2024ZW001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No