RecruitingNCT05363748

Renal Artery Fibromuscular Dysplasia Registry

A Prospective Study of the Renal Artery Fibromuscular Dysplasia Registry in China


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

500 participants

Start Date

Oct 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This registry study is collecting detailed information about people diagnosed with fibromuscular dysplasia (FMD) affecting the kidney arteries — a non-inflammatory, non-atherosclerotic disease causing abnormal artery walls — to better understand the condition and improve treatment. **You may be eligible if...** - You have been diagnosed with renal artery fibromuscular dysplasia confirmed by CT angiography, MR angiography, or catheter angiography - You have a typical 'string-of-beads' pattern or focal narrowing of the renal artery - Or you have an atypical FMD presentation such as artery dissection or multiple aneurysms in someone under 60 - You have signed informed consent **You may NOT be eligible if...** - Your artery changes are caused by a different condition (e.g., atherosclerosis or an inherited arterial disorder) - You do not consent to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

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

Shanghai, Shanghai Municipality, China

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NCT05363748