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利用者名:
UMIN ID:

試験進捗状況 参加者募集終了‐試験継続中/No longer recruiting
UMIN試験ID UMIN000039331
受付番号 R000044858
科学的試験名
一般公開日(本登録希望日) 2020/01/31
最終更新日 2020/01/31

※ 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。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on cardiovascular Percutaneous Coronary Intervention and the nature of results and conclusions of these reviews
一般向け試験名略称/Acronym
EvalPCI
科学的試験名/Scientific Title
Evaluating the relationship between industry sponsorship and conflicts of interest among systematic review authors on cardiovascular Percutaneous Coronary Intervention and the nature of results and conclusions of these reviews
科学的試験名略称/Scientific Title:Acronym
EvalPCI
試験実施地域/Region
北米/North America

対象疾患/Condition
対象疾患名/Condition
PCI in Cardiology
疾患区分1/Classification by specialty
循環器内科学/Cardiology 血管外科学/Vascular surgery
成人/Adult
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 いいえ/NO

目的/Objectives
目的1/Narrative objectives1
Over the next five minutes an average of 8 people in the US will have died from heart disease. Cardiovascular disease in the US is responsible for more deaths than any other cause with more than 605000 individuals experiencing their first heart attack and another 200000 having their second.1 The most common type of heart disease is coronary artery disease with a prevalence among adults estimated at over 18.2 million among US adults. Among those with CAD nearly 2 million people per year receive a percutaneous coronary intervention or stenting as a treatment. However, the use of PCIs especially in those with stable angina may be overused. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial does not indicate stents or bypass surgery are more effective than medication in preventing heart attacks or death than medication in persons with stable angina further supporting findings from the 2017 Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty and 2007 Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trials. Additionally the American Medical Association convened to address the use of PCIs in 2013 to update patient selection for treatment and education, and performance measures.7 The combination of CVDs prevalence rate, economic cost of nearly 220 billion annually and a large body of evidence showing that PCIs may often not be superior to medication the need for viable and sound guidelines for cardiologists to make treatment decisions is evident.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
We focused this study on the association of FCOIs within SRMAs investigating trials of PCIs.
試験の性質1/Trial characteristics_1 探索的/Exploratory
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
We focused this study on the association of FCOIs within SRMAs investigating trials of PCIs.
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 その他・メタアナリシス等/Others,meta-analysis etc

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
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
99 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
To be included in our study, the study design must be a systematic review andor metaanalysis. We will use the PRISMAP definition of a systematic review/meta-analysis which states that a systematic review is a systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify select and critically appraise relevant research and to collect and analyze data from the studies that are included in the review. Statistical methods may or may not be used to analyze and summarize the results of the included studies. Metaanalysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. Furthermore studies will be included if they compare stent placement to a pharmacologic therapy or nonpharmacologic therapy such as behavioral changes. Furthermore to qualify for inclusion systematic reviews must have been published between September of 2016 and December of 2019. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included.
除外基準/Key exclusion criteria
To be included in our study, the study design must be a systematic review andor metaanalysis. We will use the PRISMAP definition of a systematic review/meta-analysis which states that a systematic review is a systematic review is a review of a clearly formulated question that uses systematic and explicit methods to identify select and critically appraise relevant research and to collect and analyze data from the studies that are included in the review. Statistical methods may or may not be used to analyze and summarize the results of the included studies. Metaanalysis refers to the use of statistical techniques in a systematic review to integrate the results of included studies. Furthermore studies will be included if they compare stent placement to a pharmacologic therapy or nonpharmacologic therapy such as behavioral changes. Furthermore to qualify for inclusion systematic reviews must have been published between September of 2016 and December of 2019. Only systematic reviews published in English and reviews that synthesize studies of human or animal data will be included.
目標参加者数/Target sample size 50

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

ミドルネーム

Matt
ミドルネーム
Vassar
所属組織/Organization
Oklahoma State University
所属部署/Division name
CHS
郵便番号/Zip code 74107
住所/Address
1111 West 17th Street
電話/TEL 9185948426
Email/Email matt.vassar@okstate.edu

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

Matt
ミドルネーム
Vassar
組織名/Organization
Oklahoma State University
部署名/Division name
CHS
郵便番号/Zip code 74107
住所/Address
1111 West 17th Street
電話/TEL 9185948426
試験のホームページURL/Homepage URL
Email/Email matt.vassar@okstate.edu

実施責任組織/Sponsor
機関名/Institute その他 Oklahoma State 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 Oklahoma State University
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 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization
United States

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
OSU
住所/Address
111 W 174th st
電話/Tel 9185948426
Email/Email matt.vassar@okstate.edu

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
2020 01 31

関連情報/Related information
プロトコル掲載URL/URL releasing protocol OSF.IO
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications na
組み入れ参加者数/Number of participants that the trial has enrolled 50
主な結果/Results

主な結果入力日/Results date posted
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
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

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 参加者募集終了‐試験継続中/No longer recruiting
プロトコル確定日/Date of protocol fixation
2020 01 30
倫理委員会による承認日/Date of IRB
2020 01 01
登録・組入れ開始(予定)日/Anticipated trial start date
2020 02 03
フォロー終了(予定)日/Last follow-up date
2021 01 30
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information
Systematic Review

管理情報/Management information
登録日時/Registered date
2020 01 31
最終更新日/Last modified on
2020 01 31


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=R000044858
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044858

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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