Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease
1 other identifier
observational
30
0 countries
N/A
Brief Summary
We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedJuly 29, 2024
July 1, 2024
3 months
July 24, 2024
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
preoperative perfusion parameters
preoperative perfusion parameters by dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI)
Between Aug.1 2024 and OCT.31 2024
Secondary Outcomes (3)
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
Study Arms (1)
PAD group
patients of peripheral artery disease who underwent endovascular treatment
Interventions
the recruited patients should complete pre- and post-operative DCE MRI workshops
Eligibility Criteria
patients with peripheral artery disease, who had a successful endovascular treatment and completed both pre- and post-operative MRI workups
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
July 24, 2024
First Posted
July 29, 2024
Study Start
August 1, 2024
Primary Completion
October 31, 2024
Study Completion
November 30, 2024
Last Updated
July 29, 2024
Record last verified: 2024-07