Renal Artery Fibromuscular Dysplasia Registry

November 15, 2023 updated by: Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine

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

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jiguang Wang, MD, PhD
  • Phone Number: 610911 +86-21-64370045
  • Email: jiguangw@163.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Jiguang Wang, PhD
          • Phone Number: 610911 +86-21-64370045
          • Email: jiguangw@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Informed consent;
  2. 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;
  3. 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;
  4. 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;

Exclusion Criteria:

1. Not eligible for inclusion or in situations considered unqualified for the study by the investigator;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Observation group
sequential

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage of focal or multifocal FMD
Time Frame: 1 day
The percentage of focal or multifocal subtype in the renal artery FMD in China
1 day
The percentage of multivessel FMD in the renal artery FMD
Time Frame: 1 week
The percentage of multivessel FMD in the renal artery FMD in China
1 week
The change of blood pressure
Time Frame: 10 years
Comparison of blood pressure between baseline and 3/6/12 months (every year) after percutaneous transluminal angioplasty.
10 years
The rate of restenosis of renal artery FMD
Time Frame: 10 years
The rate of restenosis of renal artery FMD after percutaneous transluminal angioplasty
10 years
The rate of incidence of cardiovascular events
Time Frame: 10 years
The rate of incidence of cardiovascular events in the renal artery FMD patients, such as cerebral infarction, hypertensive nephropathy, myocardial infarction and so on.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiguang Wang, PhD, Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA-FMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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