UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039331 |
|---|---|
| Receipt number | R000044858 |
| 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 |
| Date of disclosure of the study information | 2020/01/31 |
| Last modified on | 2020/01/31 01:24:46 |
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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
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
matt.vassar@okstate.edu
Sponsor or person
Institute
Oklahoma State University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044858
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