Actively Recruiting

All Genders
NCT05363748

Renal Artery Fibromuscular Dysplasia Registry

Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-11-18

500

Participants Needed

1

Research Sites

795 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

1. Study name: A Prospective Study of the Renal artery fibromuscular dysplasia Registry in China 2. Rationale: Fibromuscular dysplasia (FMD) is an idiopathic systemic noninflammatory arterial disease resulting in narrowing of medium-sized arteries. Renal arteries are most commonly involved vessels, although it can also affect arteries in other vascular territories. Renal artery FMD is the second frequent cause of renovascular hypertension , especially in adolescents. The pathogenesis of FMD is still not understood. There were little Asians in the United States and the European/International FMD registry. 3. Objective: 1) To describe the characteristics of renal artery FMD; 2) To identify environmental/ hormonal factors and exposures (for example smoking) associated with the onset and progression of renal artery FMD; 3)To identify baseline characteristics of the disease associated with an increased risk of complications such as dissections, aneurysms, stroke or myocardial infarction; 4) To provide evidence-based algorithms for the management and follow-up of patients with renal artery FMD; 5) To establish a comprehensive imaging resource including a wide range of presentations of renal artery FMD. 4. Study design: Prospective, multi-center, observational study. 5. Study population: renal artery fibromuscular dysplasia 6. Data Collections: 1) Data on demographic characteristics, clinical characteristics, blood routine, biochemical and plasmic electrolytes and vascular imaging were collected using a questionnaire; 2) The diagnosis of renal artery FMD was based on the identification of focal or multifocal FMD lesions in at least one arterial bed by computed tomography angiography, magnetic resonance angiography and/or digital subtraction angiographies; 3) For the patients with renal artery FMD, screening was performed to assess most arteries and multivessel FMD would be collected; 4) All patients would be followed up. 7. Treatment: Standardized diagnosis and treatment procedure as recommended in the International Consensus on the diagnosis and management of fibromuscular dysplasia. 8. Follow up: 3, 6, 12 months after diagnosis and every year after enrolled. 9. Sample size estimation: About 5 hundred. 10. Timeline: Start of subjects' enrollment: Jan 2021; End of subjects enrollment: December 2026; End of study: December 2036. 11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

CONDITIONS

Official Title

Renal Artery Fibromuscular Dysplasia Registry

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Diagnosed with renal artery fibromuscular dysplasia confirmed by CT angiography, MR angiography, or catheter-based angiography
  • Patients with atypical renal artery FMD or FMD-like presentation with at least one dissection or two aneurysms under 60 years old without inherited arteriopathy
  • Patients younger than 18 years with renal artery FMD without underlying syndromes such as Williams syndrome, Alagille syndrome, or type 1 Neurofibromatosis
Not Eligible

You will not qualify if you...

  • Not eligible for inclusion or considered unqualified for the study by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025

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Research Team

J

Jiguang Wang, MD, PhD

CONTACT

J

Jiguang Wang, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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