The FMD Registry is now enrolling patients. In the first phase, there were seven sites in the United States that participated in the registry. These sites are: Cleveland Clinic in Cleveland, Ohio, Ochsner Clinic in New Orleans, LA, Mount Sinai School of Medicine, New York, NY, Mayo Clinic, Rochester, MN, Institute of Vascular Health in South Carolina, North Central Heart Institute, Sioux Falls, SD, and the University of Michigan, Ann Arbor, MI. (see updated centers list 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 monies become available, more centers will be added.
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 more 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 can accurately predict which tests/procedures/medications result in the best outcomes. It often takes time to gather enough information in order to adequately analyze the results. Based upon the current number of sites involved (which is limited by the funding available to coordinate the registry), it will most likely take up to a year before enough data is gathered to adequately analyze.
Current Participating Registry Centers
Bruce Gray, DO
Greenville Hospital, Greenville, SC
J. Michael Bacharach, MD
North Central Heart, Sioux Falls, SD
Jim Froehlich, MD
University of Michigan, Ann Arbor, MI
Chris White, MD
Ochsner Health Center, Metairie, LA
Jeffrey W. Olin, DO, FACP, FACC
Mount Sinai School of Medicine, New York, NY
Heather L. Gornik, M.D.
Cleveland Clinic Heart and Vascular Institute, Cleveland, OH
Aditya Sharma, MD
University of Virginia Health System, Charlottesville, VA
Yung-Wei Chi DO, FAHA
The Vascular Center, University of California, Davis, Sacramento, CA
Michael R. Jaff, DO
Massachuttes General Hospital, Boston, MA
Kevin Meyers, MD
Children's Hospital of Philadelphia, Philadelphia, PA
Barry Katzen, MD
Miami Baptist Cardiac/Vascular Institute, Miami, FL
Rob McBane, MD
Mayo Clinic, Rochester MN
For the past two years data from the registry has been released and the findings have caught the attention of the medical community and researchers. To date over 830 patients have enrolled in the registry and we currently have 13 participating centers.
Thank you to the FMD patients who have participated and to those who donate, together we can make a difference. As long as we can continue to fund the registry we will continue to learn, and find answers.