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The FSR is composed of two types of stroke registries:
1. Retrospective database for clinical and epidemiological studies
Information from medical records of patients with stroke from participating institutions is de-identified prior to inclusion in the database. Under the supervision of the personal information administrator in each healthcare institution, personal information is completely removed. Information from prognostic investigation, collection of samples, and genomic studies is preserved, however. Data are utilized and managed in an integrated joint database for retrospective study.
2. Prospective registry of cases with informed consent
Only information from consenting patients will be collected as linkable anonymized cases. Linkable anonymized medical records, prognostic information, plasma, and DNA samples of patients with stroke are organized into the prospective database within 7 days of onset. This linkable anonymized stroke registry is used for prospective research and strictly controlled in accordance with the “Guidelines for the Safe Management of Medical Information Systems.”
On a priority basis, plasma is aliquoted from blood extracted for diagnostic workup during hospitalization. If the amount of blood collected is inadequate , we will obtain the patient’s permission for blood extraction. DNA samples can be collected only if with informed consent. All blood samples are converted into linkable anonymized information by the personal information staff under the supervision of the personal information administrator at each medical institution. When necessary, the specimens are stored in multiple tubes in a deep freezer for future use in genomic and proteomic research. The samples are kept in a locked room which cannot be accessible without a PIN at the main research facility.
Patients who provided informed consent in the prognostic survey will be followed up regularly via telephone calls and letters from the Secretariat to confirm their health condition. In case of adverse events, we will obtain detailed clinical information from the physician in charge as needed.
This information will be integrated into the stroke database and utilized for clinical research.
Clinical Research Coordinator (CRC)
After obtaining consent from the patients, the clinical research coordinator (CRC) will support the research. CRCs are research staff who are bound by confidentiality agreements with each medical facility and are fully aware of the personal information protection.
Anonymity
Some or all personally identifiable information is removed from the samples and substituted with codes or numbers unrelated to the source.
Informed consent
Prospective patients or sample donors will receive a full explanation on the genome research and genetic analyses from a guidebook and from the research director. The patients will also be briefed on the significance of the studies, objectives, methods, and anticipated results or disadvantages. The patients will only be enrolled as clinical trial participants out of their own free will.
FSR offers a full explanation in the “Fukuoka Stroke Registry Research Cooperation Request Book.” Those who agree to voluntarily participate in the study shall sign a consent form for the Fukuoka Stroke Registry Research.
Organization
Fukuoka Stroke Registry
- Department of Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
- Department of Health Care Administration and Management, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
- Department of Nephrology, Hypertension, and Strokology, Kyushu University Hospital, Fukuoka, Japan
- Department of Cerebrovascular Disease and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
- Department of Cerebrovascular Medicine, Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital, Kitakyushu, Japan
- Department of Cerebrovascular Disease and Neurology, Nippon Steel Yawata Memorial Hospital, Kitakyushu, Japan
- Department of Cerebrovascular Disease and Neurology, National Fukuoka-Higashi Medical Center, Koga, Japan
- Department of Cerebrovascular Disease and Neurology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan
- Department of Cerebrovascular Disease, St. Maryʼs Hospital, Kurume, Japan
Steering committee and research working group
- Department of Internal Medicine, Fukuoka Dental Collage Medical and Dental Hospital, Fukuoka, Japan
- Cerebrovascular Division, Department of Medicine, National Cerebral Cardiovascular Center, Suita, Japan
- Department of Cerebrovascular Disease and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
- Department of Cerebrovascular Medicine, Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital, Kitakyushu, Japan
- Department of Cerebrovascular Disease and Neurology, Nippon Steel Yawata Memorial Hospital, Kitakyushu, Japan
- Department of Cerebrovascular Disease and Neurology, National Fukuoka-Higashi Medical Center, Koga, Japan
- Department of Cerebrovascular Disease and Neurology, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan
- Department of Cerebrovascular Disease, St. Maryʼs Hospital, Kurume, Japan
- Department of Cerebrovascular Disease, Hakujuji Hospital, Fukuoka, Japan
- Department of Cerebrovascular Disease, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan
- Department of Internal Medicine, Imazu Red Cross Hospital, Fukuoka, Japan
- Department of Internal Medicine, Seiai Rehabilitation Hospital, Onojo, Japan
FSR Collaborators
FSR collaborators are as follows: strokologists and stroke neurologists of the Research Section for Stroke, Cerebral Blood Flow and Metabolism, Department of Clinical Science, Kyushu University, and FSR-collaborative clinical research coordinators. FSR council, committee, and management regulations are as prescribed in the operations bylaws.