UMIN-CTR Clinical Trial

Basic information
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
Acronym	EvalPCI
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
Scientific Title:Acronym	EvalPCI
Region	North America

Condition
Condition	PCI in Cardiology
Classification by specialty	Cardiology Vascular surgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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.
Basic objectives2	Others
Basic objectives -Others	We focused this study on the association of FCOIs within SRMAs investigating trials of PCIs.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	We focused this study on the association of FCOIs within SRMAs investigating trials of PCIs.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
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.
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.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Matt Middle name Last name Vassar
Organization	Oklahoma State University
Division name	CHS
Zip code	74107
Address	1111 West 17th Street
TEL	9185948426
Email	matt.vassar@okstate.edu

Public contact
Name of contact person	1st name Matt Middle name Last name Vassar
Organization	Oklahoma State University
Division name	CHS
Zip code	74107
Address	1111 West 17th Street
TEL	9185948426
Homepage URL
Email	matt.vassar@okstate.edu

Sponsor
Institute	Oklahoma State University
Institute
Department

Funding Source
Organization	Oklahoma State University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	United States

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	OSU
Address	111 W 174th st
Tel	9185948426
Email	matt.vassar@okstate.edu

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 31 Day

Related information
URL releasing protocol	OSF.IO
Publication of results	Unpublished

Result
URL related to results and publications	na
Number of participants that the trial has enrolled	50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 01 Month 30 Day
Date of IRB	2020 Year 01 Month 01 Day
Anticipated trial start date	2020 Year 02 Month 03 Day
Last follow-up date	2021 Year 01 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Systematic Review

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044858