The US Registry for Fibromuscular Dysplasia
In 2007, the Fibromuscular Dysplasia Society of America (FMDSA) decided to begin a registry to better understand the disease and its treatment. The goals of this registry are to identify patient characteristics associated with FMD, potential markers of the disease, and commonly used imaging and treatment modalities, among others. Michigan Clinical Outcomes Research and Reporting Program (MCORRP) is the coordinating center for the FMD Registry. Beginning initially with 7 sites, the first patient was entered into the online database at the beginning of 2009. As of May 2021, 17 sites are active and over 3,100 patients are part of the registry. (See all sites listed below)
Since funding to support the registry is very limited, these sites were chosen by a multidisciplinary committee because they treat a large enough number of patients with FMD and thus will be able to rapidly accumulate as much information as possible. As soon as additional funding becomes available, more centers will be added.
To participate in the registry you must be seen as a patient at one of the centers listed below. Each person agreeing to participate in the registry must first sign a consent form. The consent forms are often lengthy and detailed because they are formatted similarly to those used in clinical research. It's important to remember that the FMD registry is a data registry only - no experimental research is being conducted. Clinical data is collected in a de-identified manner and placed into a database. Clinical data includes elements such as date of diagnosis, types of tests conducted and results of these tests, past medical history, family history, subsequent clinical events and any clinical outcomes.
All of these data elements are important to determine the natural course of the disease and to determine which procedures are most effective to relieve symptoms and reduce adverse outcomes.
Since patient privacy laws were enacted in 2003, physicians must have individual patients' consents to place data in a central registry. No names, addresses, social security numbers, or any personal information are included in the registry. Each patient is assigned a unique ID number which identifies individual patients to the treating physician. All staff involved with the registry can identify sites and patients by numbers only. Many measures are taken to secure the information including multiple firewalls, encryption codes, and de-identifiers.
Since FMD is not commonly recognized and often misdiagnosed, the only way to gather enough information to learn how to better diagnose and treat patients is to form a data registry which allows collection of many cases from multiple institutions. With large numbers of cases, physicians can create statistical models that accurately predict which tests/procedures/medications result in the best outcomes.
The initial findings from the registry were published in the medical journal Circulation in 2012. A Patient Page was also published the same year in Circulation. In 2013, an article describing the differences in the disease between men and women was published in the Journal of the American College of Cardiology. In February 2014, an AHA Scientific Statement was published in Circulation, highlighting best practices in the care of FMD and avenues for future research. Researchers have also been able to present many abstracts and posters at national meetings with information gained from the registry. To date, almost 40 manuscripts, abstracts and posters have been published and presented with data from the patient registry.
Thank you to the FMD patients who have participated and to those who donate, together we can make a difference. As we continue to fund the registry we will continue to learn and find answers.
As of May 2021, over 3,100 patients have participated in the Patient Registry
Currently there are 17 Participating Registry Centers
J. Michael Bacharach, MD
North Central Heart, Sioux Falls, SD
James B. Froehlich, MD, MPH
University of Michigan, Ann Arbor, MI
Natalia Fendrikova Mahlay, MD
Cleveland Clinic Heart and Vascular Institute, Cleveland, OH
Heather L. Gornik, MD
University Hospitals Cleveland Medical Center, Cleveland, OH
Bruce Gray, DO
Prisma Health - Upstate, Greenville, SC
Kamal Gupta, MD
University of Kansas, Kansas City, KS
Ido Weinberg, MD
Massachusetts General Hospital, Boston, MA
Barry Katzen, MD, FACR, FACC, FSIR
Miami Baptist Cardiac/Vascular Institute, Miami, FL
Kevin Meyers, MD
Children's Hospital of Philadelphia, Philadelphia, PA
Esther Kim, MD, MPH
Vanderbilt University Medical Center, Nashville, TN
Aditya Sharma, MD
University of Virginia Health System, Charlottesville, VA
Eri Fukaya, MD, PhD
Stanford Vascular Clinics, Stanford, Ca
Kevin Rogers, MD
University of Colorado, Aurora, CO