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NCT Number: NCT06525415

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DCE MRI

Diagnostic Test

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

Primary outcomes

  1. preoperative perfusion parameters

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

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

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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