Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05363748 |
| Other study ID # |
RA-FMD |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
December 31, 2036 |
Study information
| Verified date |
November 2023 |
| Source |
Shanghai Jiao Tong University School of Medicine |
| Contact |
Jiguang Wang, MD, PhD |
| Phone |
+86-21-64370045 |
| Email |
jiguangw[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
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 and causes stenosis,
aneurysm, occlusion, or dissection. 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 (RVH), especially in adolescents.
FMD often affects two or more arterial beds (prevalence of multivessel FMD: 57 to 66%).
Despite traditional views on the role of female hormones, mechanical factors and, more
recently, smoking, the pathophysiology of FMD is still not well 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 in men and women,
older and younger patients and according to different arterial manifestations, ethnic
origin in order to individualize management and prevent complications; 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 optimal 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, which may be used to improve knowledge and raise awareness in the medical
community.
4. Study design: Prospective, multi-center, observational study.
5. Study 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.
6. Data Collections: 1) Data on demographic characteristics (age, gender, height, and
ethnicity), clinical characteristics [seated office systolic and diastolic blood
pressure (BP), smoking, family history on hypertension or FMD, concomitant diseases,
current medications, age at diagnosis of renal artery FMD, angiographic subtype of renal
artery FMD, symptoms of renal artery FMD at diagnosis and associated atheroma lesions],
blood routine, biochemical and plasmic electrolytes and vascular imaging (arterial beds
explored, imaging modality, type, and site of lesions for each vascular bed) 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 (CTA), magnetic resonance angiography(MRA) and/or
digital subtraction angiographies (DSA), as recommended in the first international FMD
Consensus; 3) For the patients with renal artery FMD, screening was performed to assess
all arteries (for example: cerebrovascular, mesenteric, aorta, renal, coronary,
visceral, upper and lower extremity arteries) and multivessel FMD would be collected. 4)
All patients would be followed up and data ( for example: the blood pressure and
restenosis) would be evaluated again.
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.
