RT Journal Article
SR Electronic
T1 Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e038623
DO 10.1136/bmjopen-2020-038623
VO 10
IS 9
A1 Hayato Tada
A1 Hirofumi Okada
A1 Shohei Yoshida
A1 Masaya Shimojima
A1 Akihiro Nomura
A1 Toyonobu Tsuda
A1 Mika Mori
A1 Shin-ichiro Takashima
A1 Takeshi Kato
A1 Soichiro Usui
A1 Kenji Sakata
A1 Kenshi Hayashi
A1 Noboru Fujino
A1 Akihiro Inazu
A1 Shizuko Takahara
A1 Yasuhito Imai
A1 Takao Matsubara
A1 Atsushi Nohara
A1 Kenji Miwa
A1 Masanobu Namura
A1 Hidenobu Terai
A1 Taiji Yoshida
A1 Tsutomu Araki
A1 Masahiro Minamoto
A1 Toru Aburao
A1 Yuji Ito
A1 Chiaki Nakanishi
A1 Suguru Kawasaki
A1 Yasuhiro Todo
A1 Junji Koizumi
A1 Yoshihito Kita
A1 Hiroshi Matsumoto
A1 Hiroaki Shintaku
A1 Akihiko Hodatsu
A1 Hidekazu Ino
A1 Toshinori Higashikata
A1 Mutsuko Takata
A1 Katsushi Misawa
A1 Masato Yamaguchi
A1 Yoshihiro Noji
A1 Kazuo Osato
A1 Tomohito Mabuchi
A1 Taro Ichise
A1 Bunji Kaku
A1 Shoji Katsuda
A1 Manabu Fujimoto
A1 Katsuharu Uchiyama
A1 Kensuke Fujioka
A1 Takuya Nakahashi
A1 Tsuyoshi Nozue
A1 Ichiro Michishita
A1 Kazuo Usuda
A1 Kanichi Otowa
A1 Kazuyasu Okeie
A1 Satoshi Hirota
A1 Isao Aburadani
A1 Keisuke Kurokawa
A1 Osamu Takatori
A1 Shunichiro Hondo
A1 Hiroyuki Oda
A1 Shigeo Takata
A1 Hisayoshi Murai
A1 Masaki Kinoshita
A1 Hideo Nagai
A1 Yoshiteru Sekiguchi
A1 Satoru Sakagami
A1 Wataru Omi
A1 Chikara Fujita
A1 Tatsuo Katsuki
A1 Hiroshi Ootsuji
A1 Atsushi Igarashi
A1 Manabu Nakano
A1 Seiichiro Okura
A1 Koji Maeno
A1 Yasuhito Mitamura
A1 Naoki Sugimoto
A1 Masakazu Yamamoto
A1 Hironobu Akao
A1 Kouji Kajinami
A1 Masayuki Takamura
A1 Masa-aki Kawashiri
YR 2020
UL http://bmjopen.bmj.com/content/10/9/e038623.abstract
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.