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Status unknownNCT06525415Updated Jul 29, 2024

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

An observational study in Peripheral Arterial Disease and Perfusion, sponsored by Fudan University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Fudan University · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Peripheral Arterial Disease
  • Perfusion
03

In context

Peripheral Arterial Disease

1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.

This study's planned enrollment of 30 is below the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • PAD group

    patients of peripheral artery disease who underwent endovascular treatment

    Diagnostic Test: DCE MRI

Interventions

  • Diagnostic testDCE MRI

    the recruited patients should complete pre- and post-operative DCE MRI workshops

06

What researchers measure

Primary outcomes

  1. preoperative perfusion parameters

    preoperative perfusion parameters by dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI)

    Time frame: Between Aug.1 2024 and OCT.31 2024

Secondary outcomes

  1. ankle brachial index

    Time frame: Between Aug.1 2024 and OCT.31 2024

  2. clinical success

    Time frame: Between Aug.1 2024 and NOV.30 2024

  3. survival

    Time frame: Between Aug.1 2024 and NOV.30 2024

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Zhou K, Chen C, Du S, Zhang J, Li S, Zhu T, Dong Y, Zhang W. Foot dynamic contrast-enhanced MRI for assessing microcirculatory changes after endovascular therapy in peripheral artery disease: A prospective pilot study. Magn Reson Imaging. 2026 Nov;133:110740. doi: 10.1016/j.mri.2026.110740. Epub 2026 Jul 2. PubMed 42392285 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2024; primary completion for Oct 2024, 2 months later.

Of 139 non-industry observational studies under Peripheral Arterial Disease, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 116. This study's planned 2 months is below that.

Counting every sponsor, half of 197 studies reached it within 37 months; a quarter within 23 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2024
First posted
Jul 29, 2024
StartEst.
Aug 1, 2024
Primary completionEst.
Oct 31, 2024
CompletionEst.
Nov 30, 2024
Last update
Jul 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06525415
Lead sponsor
Fudan University
Responsible party
Zhijun Bao (Director, Fudan University) — Principal investigator
First posted
Jul 29, 2024
Start date
Aug 1, 2024 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Jul 29, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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