PT  - JOURNAL ARTICLE
AU  - Hayato Tada
AU  - Hirofumi Okada
AU  - Shohei Yoshida
AU  - Masaya Shimojima
AU  - Akihiro Nomura
AU  - Toyonobu Tsuda
AU  - Mika Mori
AU  - Shin-ichiro Takashima
AU  - Takeshi Kato
AU  - Soichiro Usui
AU  - Kenji Sakata
AU  - Kenshi Hayashi
AU  - Noboru Fujino
AU  - Akihiro Inazu
AU  - Shizuko Takahara
AU  - Yasuhito Imai
AU  - Takao Matsubara
AU  - Atsushi Nohara
AU  - Kenji Miwa
AU  - Masanobu Namura
AU  - Hidenobu Terai
AU  - Taiji Yoshida
AU  - Tsutomu Araki
AU  - Masahiro Minamoto
AU  - Toru Aburao
AU  - Yuji Ito
AU  - Chiaki Nakanishi
AU  - Suguru Kawasaki
AU  - Yasuhiro Todo
AU  - Junji Koizumi
AU  - Yoshihito Kita
AU  - Hiroshi Matsumoto
AU  - Hiroaki Shintaku
AU  - Akihiko Hodatsu
AU  - Hidekazu Ino
AU  - Toshinori Higashikata
AU  - Mutsuko Takata
AU  - Katsushi Misawa
AU  - Masato Yamaguchi
AU  - Yoshihiro Noji
AU  - Kazuo Osato
AU  - Tomohito Mabuchi
AU  - Taro Ichise
AU  - Bunji Kaku
AU  - Shoji Katsuda
AU  - Manabu Fujimoto
AU  - Katsuharu Uchiyama
AU  - Kensuke Fujioka
AU  - Takuya Nakahashi
AU  - Tsuyoshi Nozue
AU  - Ichiro Michishita
AU  - Kazuo Usuda
AU  - Kanichi Otowa
AU  - Kazuyasu Okeie
AU  - Satoshi Hirota
AU  - Isao Aburadani
AU  - Keisuke Kurokawa
AU  - Osamu Takatori
AU  - Shunichiro Hondo
AU  - Hiroyuki Oda
AU  - Shigeo Takata
AU  - Hisayoshi Murai
AU  - Masaki Kinoshita
AU  - Hideo Nagai
AU  - Yoshiteru Sekiguchi
AU  - Satoru Sakagami
AU  - Wataru Omi
AU  - Chikara Fujita
AU  - Tatsuo Katsuki
AU  - Hiroshi Ootsuji
AU  - Atsushi Igarashi
AU  - Manabu Nakano
AU  - Seiichiro Okura
AU  - Koji Maeno
AU  - Yasuhito Mitamura
AU  - Naoki Sugimoto
AU  - Masakazu Yamamoto
AU  - Hironobu Akao
AU  - Kouji Kajinami
AU  - Masayuki Takamura
AU  - Masa-aki Kawashiri
TI  - Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design
AID  - 10.1136/bmjopen-2020-038623
DP  - 2020 Sep 01
TA  - BMJ Open
PG  - e038623
VI  - 10
IP  - 9
4099  - http://bmjopen.bmj.com/content/10/9/e038623.short
4100  - http://bmjopen.bmj.com/content/10/9/e038623.full
SO  - BMJ Open2020 Sep 01; 10
AB  - Introduction Familial 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 analysis The 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 dissemination This 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 number UMIN000038210.