About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Informed consent;
Patients diagnosed with renal artery fibromuscular dysplasia (FMD), i.e. at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). The diagnosis needs to be confirmed by at least one of the following imaging modalities: CT-angiography, MR-angiography or catheter-based angiography;
Patients with so-called "atypical renal artery FMD" or "renal artery FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms < 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy;
Patients with established renal artery FMD younger than 18 years, without evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis;
Disqualifiers
None
Trial population
patients with renal artery fibromuscular dysplasia who signed the informed consent will be eligible. The following patients are eligible for inclusion: 1) Patients with established renal artery FMD, at least one string-of-beads (multifocal FMD) or focal stenosis (focal FMD). 2) Patients with so-called "atypical FMD" or "FMD-like presentation", i.e. patients presenting with at least one dissection or 2 aneurysms \< 60-year-old, in the absence string-of-beads, focal stenosis or evidence of inherited arteriopathy. 3) Children with renal artery FMD may be also included, provided they meet the inclusion criteria and there is no evidence of underlying syndromes such as Williams syndrome, Alagille syndrome or type 1 Neurofibromatosis.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The percentage of focal or multifocal FMD
The percentage of focal or multifocal subtype in the renal artery FMD in China
The percentage of multivessel FMD in the renal artery FMD
The percentage of multivessel FMD in the renal artery FMD in China
The change of blood pressure
Comparison of blood pressure between baseline and 3/6/12 months (every year) after percutaneous transluminal angioplasty.
The rate of restenosis of renal artery FMD
The rate of restenosis of renal artery FMD after percutaneous transluminal angioplasty
Sponsors and contacts
Click on the lead sponsor to view all of their trials.