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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000038129
受付番号 R000043458
科学的試験名
一般公開日(本登録希望日) 2019/09/27
最終更新日 2020/05/22

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
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基本情報/Basic information
一般向け試験名/Public title
Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
一般向け試験名略称/Acronym
Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
科学的試験名/Scientific Title
Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
科学的試験名略称/Scientific Title:Acronym
Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition
patient of aortic valve stenosis and health people
疾患区分1/Classification by specialty
循環器内科学/Cardiology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information はい/YES

目的/Objectives
目的1/Narrative objectives1
It remains unknown whether DNA methylation in peripheral blood cells is related to pathogenesis of Aortic Valve Stenosis(AS).
The aim of the present study was to perform an epigenome-wide association study (EWAS) for AS with two different groups (discovery and replicate), to identify AS-specific alterations in DNA methylation in peripheral blood mononuclear cells (PBMC). In addition, the present study evaluated the effects of surgical treatments on the levels of DNA methylation and its related transcription.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
identify AS-specific alterations in DNA methylation in peripheral blood mononuclear cells.
試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2 その他/Others
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
identifies a novel DNA methylation in patients with severe aortic valve stenosis
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 観察/Observational

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Symptomatic AS, An aortic valve area of < 1.0 cm2, An aortic valve area index of < 0.6 cm2/m2, Mean aortic gradient > 40 mmHg or peak aortic velocity > 4 m / second
除外基準/Key exclusion criteria
clinical signs of acute coronary syndrome, acute infection, severe renal failure (serum creatine levels over 3 mg/dL) or rheumatoid disease, or if they were suspected of having a malignant or primary wasting disorder
目標参加者数/Target sample size 200

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Mamoru
ミドルネーム
Satoh
所属組織/Organization
Iwate Medical University
所属部署/Division name
Division of Biomedical Information Analysis, Institute for Biomedical Sciences
郵便番号/Zip code 028-3694
住所/Address
1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate , Japa
電話/TEL +81-19-613-7111
Email/Email satohm@iwate-med.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Takahito
ミドルネーム
Nasu
組織名/Organization
Iwate Medical University
部署名/Division name
Division of Biomedical Information Analysis, Institute for Biomedical Sciences
郵便番号/Zip code 028-3694
住所/Address
1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate , Japan
電話/TEL +81-19-613-7111
試験のホームページURL/Homepage URL
Email/Email tnasu@iwate-med.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Iwate Medical University
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 AMED
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 日本の官庁/Japanese Governmental office
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Ethical Review Board of Iwate Medical University
住所/Address
1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate , Japan
電話/Tel +81-19-613-7111
Email/Email kenkyu-rinri@j.iwate-med.ac.jp

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 09 27

関連情報/Related information
プロトコル掲載URL/URL releasing protocol Under preparation at our university
試験結果の公開状況/Publication of results 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications https://www.ahajournals.org/doi/10.1161/CIRCGEN.119.002649
組み入れ参加者数/Number of participants that the trial has enrolled 188
主な結果/Results
EWAS revealed that DNA methylation of a CpG site differed significantly between the AS group and controls. The DNA methyltion level of chromosome 8 position 126448033, which is located at TRIB1 (tribbles homolog 1), was lower in the AS group than in the controls
主な結果入力日/Results date posted
2020 05 22
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
2020 01 12
参加者背景/Baseline Characteristics
There were no significant differences in the number of subjects, age and proportion of males between the AS group and controls in both discovery and replication studies. There were significant differences in blood pressure and lipid profile between the AS group and controls in both discovery and replication studies. There were significant differences in the prevalence of use of some medications including diuretics, beta-blockers, statins, angiotensin converting enzymes (ACEI), angiotensin receptor blockers (ARB) and calcium channel blockers (CCB) between the discovery and replication studies).
参加者の流れ/Participant flow
Peripheral blood was collected from patients with AS for baseline data before surgical treatment and again 12 months after surgical treatment (aortic valve replacement [AVR] or transcatheter aortic valve implantation [TAVI]) and from the controls.
有害事象/Adverse events
no
評価項目/Outcome measures
deteced CpG site hypomethylation rate
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2014 04 11
倫理委員会による承認日/Date of IRB
2014 05 26
登録・組入れ開始(予定)日/Anticipated trial start date
2014 06 01
フォロー終了(予定)日/Last follow-up date
2018 11 30
入力終了(予定)日/Date of closure to data entry
2019 03 15
データ固定(予定)日/Date trial data considered complete
2019 06 20
解析終了(予定)日/Date analysis concluded
2019 09 30

その他/Other
その他関連情報/Other related information
Currently under analysis by EWAS, unknown

管理情報/Management information
登録日時/Registered date
2019 09 27
最終更新日/Last modified on
2020 05 22


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043458
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043458

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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