Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design
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 quit...
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2020-09-01
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| author | Hiroshi Matsumoto Akihiro Nomura Hayato Tada Hirofumi Okada Atsushi Nohara Masa-aki Kawashiri Koji Maeno Manabu Fujimoto Shohei Yoshida Masaya Shimojima Toyonobu Tsuda Mika Mori Shin-ichiro Takashima Takeshi Kato Soichiro Usui Kenji Sakata Kenshi Hayashi Noboru Fujino Akihiro Inazu Shizuko Takahara Yasuhito Imai Takao Matsubara Kenji Miwa Masanobu Namura Hidenobu Terai Taiji Yoshida Tsutomu Araki Masahiro Minamoto Toru Aburao Yuji Ito Chiaki Nakanishi Suguru Kawasaki Yasuhiro Todo Junji Koizumi Yoshihito Kita Hiroaki Shintaku Akihiko Hodatsu Hidekazu Ino Toshinori Higashikata Mutsuko Takata Katsushi Misawa Masato Yamaguchi Yoshihiro Noji Kazuo Osato Tomohito Mabuchi Taro Ichise Bunji Kaku Shoji Katsuda Katsuharu Uchiyama Kensuke Fujioka Takuya Nakahashi Tsuyoshi Nozue Ichiro Michishita Kazuo Usuda Kanichi Otowa Kazuyasu Okeie Satoshi Hirota Isao Aburadani Keisuke Kurokawa Osamu Takatori Shunichiro Hondo Hiroyuki Oda Shigeo Takata Hisayoshi Murai Masaki Kinoshita Hideo Nagai Yoshiteru Sekiguchi Satoru Sakagami Wataru Omi Chikara Fujita Tatsuo Katsuki Hiroshi Ootsuji Atsushi Igarashi Manabu Nakano Seiichiro Okura Yasuhito Mitamura Naoki Sugimoto Masakazu Yamamoto Hironobu Akao Kouji Kajinami Masayuki Takamura |
| author_facet | Hiroshi Matsumoto Akihiro Nomura Hayato Tada Hirofumi Okada Atsushi Nohara Masa-aki Kawashiri Koji Maeno Manabu Fujimoto Shohei Yoshida Masaya Shimojima Toyonobu Tsuda Mika Mori Shin-ichiro Takashima Takeshi Kato Soichiro Usui Kenji Sakata Kenshi Hayashi Noboru Fujino Akihiro Inazu Shizuko Takahara Yasuhito Imai Takao Matsubara Kenji Miwa Masanobu Namura Hidenobu Terai Taiji Yoshida Tsutomu Araki Masahiro Minamoto Toru Aburao Yuji Ito Chiaki Nakanishi Suguru Kawasaki Yasuhiro Todo Junji Koizumi Yoshihito Kita Hiroaki Shintaku Akihiko Hodatsu Hidekazu Ino Toshinori Higashikata Mutsuko Takata Katsushi Misawa Masato Yamaguchi Yoshihiro Noji Kazuo Osato Tomohito Mabuchi Taro Ichise Bunji Kaku Shoji Katsuda Katsuharu Uchiyama Kensuke Fujioka Takuya Nakahashi Tsuyoshi Nozue Ichiro Michishita Kazuo Usuda Kanichi Otowa Kazuyasu Okeie Satoshi Hirota Isao Aburadani Keisuke Kurokawa Osamu Takatori Shunichiro Hondo Hiroyuki Oda Shigeo Takata Hisayoshi Murai Masaki Kinoshita Hideo Nagai Yoshiteru Sekiguchi Satoru Sakagami Wataru Omi Chikara Fujita Tatsuo Katsuki Hiroshi Ootsuji Atsushi Igarashi Manabu Nakano Seiichiro Okura Yasuhito Mitamura Naoki Sugimoto Masakazu Yamamoto Hironobu Akao Kouji Kajinami Masayuki Takamura |
| author_sort | Hiroshi Matsumoto |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-917dd099aa3a44eba50203d24f5b2dba |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-917dd099aa3a44eba50203d24f5b2dba2025-01-08T03:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-038623Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study designHiroshi Matsumoto0Akihiro Nomura1Hayato Tada2Hirofumi Okada3Atsushi Nohara4Masa-aki Kawashiri5Koji Maeno6Manabu Fujimoto7Shohei Yoshida8Masaya Shimojima9Toyonobu Tsuda10Mika Mori11Shin-ichiro Takashima12Takeshi Kato13Soichiro Usui14Kenji Sakata15Kenshi Hayashi16Noboru Fujino17Akihiro Inazu18Shizuko Takahara19Yasuhito Imai20Takao Matsubara21Kenji Miwa22Masanobu Namura23Hidenobu Terai24Taiji Yoshida25Tsutomu Araki26Masahiro Minamoto27Toru Aburao28Yuji Ito29Chiaki Nakanishi30Suguru Kawasaki31Yasuhiro Todo32Junji Koizumi33Yoshihito Kita34Hiroaki Shintaku35Akihiko Hodatsu36Hidekazu Ino37Toshinori Higashikata38Mutsuko Takata39Katsushi Misawa40Masato Yamaguchi41Yoshihiro Noji42Kazuo Osato43Tomohito Mabuchi44Taro Ichise45Bunji Kaku46Shoji Katsuda47Katsuharu Uchiyama48Kensuke Fujioka49Takuya Nakahashi50Tsuyoshi Nozue51Ichiro Michishita52Kazuo Usuda53Kanichi Otowa54Kazuyasu Okeie55Satoshi Hirota56Isao Aburadani57Keisuke Kurokawa58Osamu Takatori59Shunichiro Hondo60Hiroyuki Oda61Shigeo Takata62Hisayoshi Murai63Masaki Kinoshita64Hideo Nagai65Yoshiteru Sekiguchi66Satoru Sakagami67Wataru Omi68Chikara Fujita69Tatsuo Katsuki70Hiroshi Ootsuji71Atsushi Igarashi72Manabu Nakano73Seiichiro Okura74Yasuhito Mitamura75Naoki Sugimoto76Masakazu Yamamoto77Hironobu Akao78Kouji Kajinami79Masayuki Takamura80Department of Internal Medicine, Wajima City Hospital, Wajima, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiology, Ishikawa Prefectural Central Hospital, Kanazawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiology, Fukui-ken Saiseikai Hospital, Fukui, JapanDepartment of Cardiology, Koseiren Takaoka Hospital, Takaoka, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, JapanDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, JapanDepartment of Cardiovascular and Internal Medicine, Kanazawa University Hospital, Kanazawa, Ishikawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanDepartment of Laboratory Science, Molecular Biochemistry and Molecular Biology, Graduate School of Medical Science, Kanazawa University, Kanazawa, JapanInnovative Clinical Research Center, Kanazawa University (iCREK), Kanazawa, JapanInnovative Clinical Research Center, Kanazawa University (iCREK), Kanazawa, JapanDepartment of Cardiology, Ishikawa Prefectural Central Hospital, Kanazawa, JapanDepartment of Cardiology, Ishikawa Prefectural Central Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa Cardiovascular Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa Cardiovascular Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa Cardiovascular Hospital, Kanazawa, JapanDivision of Internal Medicine, Saiseikai Kanazawa Hospital, Kanazawa, JapanDepartment of Internal Medicine, JCHO Kanazawa Hospital, Kanazawa, JapanDepartment of Internal Medicine, JCHO Kanazawa Hospital, Kanazawa, JapanDepartment of Internal Medicine, KKR Hokuriku Hospital, Kanazawa, JapanDepartment of Internal Medicine, KKR Hokuriku Hospital, Kanazawa, JapanDepartment of Internal Medicine, Kanazawa-Nishi Hospital, Kanazawa, JapanDepartment of Internal Medicine, Hokuriku Central Hospital of Japan Mutual Aid Association of Public School Teachers, Oyabe, JapanDepartment of Internal Medicine, Suzu City General Hospital, Suzu, JapanDepartment of Internal Medicine, Wajima City Hospital, Wajima, JapanDepartment of Internal Medicine, Wajima City Hospital, Wajima, JapanDepartment of Cardiology, Keiju General Hospital, Nanao, JapanDepartment of Cardiology, Houju Memorial Hospital, Nomi, JapanDepartment of Internal Medicine, Komatsu Municipal Hospital, Komatsu, JapanDepartment of Internal Medicine, Komatsu Municipal Hospital, Komatsu, JapanDepartment of Internal Medicine, Kaga Medical Center, Kaga, JapanDepartment of Cardiology, Fukui Prefectural Hospital, Fukui, JapanDepartment of Cardiology, Fukui Prefectural Hospital, Fukui, JapanDepartment of Cardiology, Fukui CardioVascular Center, Fukui, JapanDepartment of Cardiology, Fukui CardioVascular Center, Fukui, JapanDepartment of Cardiology, Fukui CardioVascular Center, Fukui, JapanDepartment of Cardiology, Toyama Red Cross Hospital, Toyama, JapanDepartment of Cardiology, Toyama Red Cross Hospital, Toyama, JapanDepartment of Cardiology, Koseiren Takaoka Hospital, Takaoka, JapanDepartment of Cardiology, Koseiren Takaoka Hospital, Takaoka, JapanDepartment of Cardiology, Takaoka City Hospital, Takaoka, JapanDepartment of Cardiology, Yokohama Sakae Kyosai Hospital, Yokohama, JapanDepartment of Cardiology, Yokohama Sakae Kyosai Hospital, Yokohama, JapanDivision of Cardiology, Department of Internal Medicine, Toyama Prefectural Central Hospital, Toyama, JapanDivision of Cardiology, Department of Internal Medicine, Toyama Prefectural Central Hospital, Toyama, JapanDepartment of Cardiology, Toyama City Hospital, Toyama, JapanDepartment of Cardiology, Kurobe City Hospital, Kurobe, JapanDepartment of Cardiology, Kurobe City Hospital, Kurobe, JapanDepartment of Cardiology, Tonami General Hospital, Tonami, JapanDepartment of Cardiology, Tonami General Hospital, Tonami, JapanDepartment of Cardiology, Public Central Hospital of Matto Ishikawa, Hakusan, JapanDepartment of Cardiology, Public Central Hospital of Matto Ishikawa, Hakusan, JapanDepartment of Cardiology, Kanazawa City Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa City Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa Arimatsu Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa Red Cross Hospital, Kanazawa, JapanDepartment of Cardiology, Kanazawa Red Cross Hospital, Kanazawa, JapanDepartment of Cardiology, National Hospital Organization, Kanazawa Medical Center, Kanazawa, Ishikawa, JapanDepartment of Cardiology, National Hospital Organization Kanazawa Medical Center, Kanazawa, JapanDepartment of Cardiology, Yawata Medical Center, Komatsu, JapanDepartment of Cardiology, Yawata Medical Center, Komatsu, JapanDepartment of Internal Medicine, Hakui Public Hospital, Hakui, JapanDepartment of Internal Medicine, Hakui Public Hospital, Hakui, JapanDepartment of Internal Medicine, Noto General Hospital, Nanao, JapanDepartment of Internal Medicine, Fukui-ken Saiseikai Hospital, Fukui, JapanDepartment of Cardiology, Municipal Tsuruga Hospital, Tsuruga, Japan1Institute of Rheumatology Tokyo Women’s Medical University, Tokyo, JapanDepartment of Cardiology, Kouseiren Namerikawa Hospital, Namerikawa, JapanDivision of Cardiology, Kanazawa Medical University Hospital, Kahoku-gun, JapanDivision of Cardiology, Kanazawa Medical University Hospital, Kahoku-gun, JapanDepartment of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences, Kanazawa, JapanIntroduction 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.https://bmjopen.bmj.com/content/10/9/e038623.full |
| spellingShingle | Hiroshi Matsumoto Akihiro Nomura Hayato Tada Hirofumi Okada Atsushi Nohara Masa-aki Kawashiri Koji Maeno Manabu Fujimoto Shohei Yoshida Masaya Shimojima Toyonobu Tsuda Mika Mori Shin-ichiro Takashima Takeshi Kato Soichiro Usui Kenji Sakata Kenshi Hayashi Noboru Fujino Akihiro Inazu Shizuko Takahara Yasuhito Imai Takao Matsubara Kenji Miwa Masanobu Namura Hidenobu Terai Taiji Yoshida Tsutomu Araki Masahiro Minamoto Toru Aburao Yuji Ito Chiaki Nakanishi Suguru Kawasaki Yasuhiro Todo Junji Koizumi Yoshihito Kita Hiroaki Shintaku Akihiko Hodatsu Hidekazu Ino Toshinori Higashikata Mutsuko Takata Katsushi Misawa Masato Yamaguchi Yoshihiro Noji Kazuo Osato Tomohito Mabuchi Taro Ichise Bunji Kaku Shoji Katsuda Katsuharu Uchiyama Kensuke Fujioka Takuya Nakahashi Tsuyoshi Nozue Ichiro Michishita Kazuo Usuda Kanichi Otowa Kazuyasu Okeie Satoshi Hirota Isao Aburadani Keisuke Kurokawa Osamu Takatori Shunichiro Hondo Hiroyuki Oda Shigeo Takata Hisayoshi Murai Masaki Kinoshita Hideo Nagai Yoshiteru Sekiguchi Satoru Sakagami Wataru Omi Chikara Fujita Tatsuo Katsuki Hiroshi Ootsuji Atsushi Igarashi Manabu Nakano Seiichiro Okura Yasuhito Mitamura Naoki Sugimoto Masakazu Yamamoto Hironobu Akao Kouji Kajinami Masayuki Takamura Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design BMJ Open |
| title | Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design |
| title_full | Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design |
| title_fullStr | Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design |
| title_full_unstemmed | Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design |
| title_short | Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design |
| title_sort | hokuriku plus familial hypercholesterolaemia registry study rationale and study design |
| url | https://bmjopen.bmj.com/content/10/9/e038623.full |
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