Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design
| Autor: | Yoshiteru Sekiguchi, Koji Maeno, Taiji Yoshida, Kazuo Usuda, Junji Koizumi, Manabu Nakano, Katsushi Misawa, Kensuke Fujioka, Isao Aburadani, Katsuharu Uchiyama, Hideo Nagai, Shohei Yoshida, Masakazu Yamamoto, Mika Mori, Masaya Shimojima, Shizuko Takahara, Kouji Kajinami, Taro Ichise, Bunji Kaku, Tomohito Mabuchi, Noboru Fujino, Yuji Ito, Shunichiro Hondo, Osamu Takatori, Masa-aki Kawashiri, Chikara Fujita, Masato Yamaguchi, Hiroshi Ootsuji, Masanobu Namura, Kazuyasu Okeie, Yoshihito Kita, Akihiko Hodatsu, Hirofumi Okada, Satoru Sakagami, Hidekazu Ino, Satoshi Hirota, Hidenobu Terai, Hironobu Akao, Kenji Sakata, Atsushi Igarashi, Toyonobu Tsuda, Seiichiro Okura, Hiroshi Matsumoto, Tsuyoshi Nozue, Suguru Kawasaki, Masahiro Minamoto, Masayuki Takamura, Yasuhiro Todo, Soichiro Usui, Toru Aburao, Tatsuo Katsuki, Ichiro Michishita, Wataru Omi, Kenshi Hayashi, Tsutomu Araki, Naoki Sugimoto, Atsushi Nohara, Kazuo Osato, Hiroaki Shintaku, Shigeo Takata, Shinichiro Takashima, Mutsuko Takata, Toshinori Higashikata, Takuya Nakahashi, Kenji Miwa, Kanichi Otowa, Yasuhito Mitamura, Hisayoshi Murai, Akihiro Nomura, Hiroyuki Oda, Hayato Tada, Takeshi Kato, Manabu Fujimoto, Masaki Kinoshita, Akihiro Inazu, Shoji Katsuda, Yoshihiro Noji, Chiaki Nakanishi, Yasuhito Imai, Keisuke Kurokawa, Takao Matsubara |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Registry study Disease Cohort Studies Hyperlipoproteinemia Type II Japan adult cardiology Diabetes mellitus lipid disorders Clinical endpoint Humans Medicine genetics Prospective Studies Registries Nutrition and Metabolism business.industry General Medicine medicine.disease Institutional review board Family medicine Observational study business Cohort study Declaration of Helsinki |
| Zdroj: | BMJ Open BMJ Open, Vol 10, Iss 9 (2020) |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-038623 |
| Popis: | IntroductionFamilial hypercholesterolaemia (FH) is an autosomal-dominant inherited genetic disease. It carries an extremely high cardiovascular risk associated with significantly elevated low-density lipoprotein (LDL) cholesterol. The diagnostic rate of this disease in some European nations is quite high, due to the presence of multiple prospective registries. On the other hand, few data—and in particular multicentre data—exist regarding this issue among Japanese subjects. Therefore, this study intends to assemble a multicentre registry that aims to comprehensively assess cardiovascular risk among Japanese FH patients while taking into account their genetic backgrounds.Methods and analysisThe Hokuriku-plus FH registry is a prospective, observational, multicentre cohort study, enrolling consecutive FH patients who fulfil the clinical criteria of FH in Japan from 37 participating hospitals mostly in Hokuriku region of Japan from April 2020 to March 2024. A total of 1000 patients will be enrolled into the study, and we plan to follow-up participants over 5 years. We will collect clinical parameters, including lipids, physical findings, genetic backgrounds and clinical events covering atherosclerotic and other important events, such as malignancies. The primary endpoint of this study is new atherosclerotic cardiovascular disease (ASCVD) events. The secondary endpoints are as follows: LDL cholesterol, secondary ASCVD events and the occurrence of other diseases including hypertension, diabetes and malignancies.Ethics and disseminationThis study is being conducted in compliance with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and all other applicable laws and guidelines in Japan. This study protocol has been approved by the Institutional Review Board at Kanazawa University. We will disseminate the final results at international conferences and in a peer-reviewed journal.Trial registration numberUMIN000038210. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|