UMIN-CTR Clinical Trial

Basic information
Public title	Health economics-based verification of functional myocardial ischemia evaluation of stable coronary artery disease
Acronym	Health economics-based verification of functional myocardial ischemia evaluation of stable coronary artery disease
Scientific Title	Health economics-based verification of functional myocardial ischemia evaluation of stable coronary artery disease
Scientific Title:Acronym	Health economics-based verification of functional myocardial ischemia evaluation of stable coronary artery disease
Region	Japan

Condition
Condition	stable coronary artery disease
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To contribute to the appropriate elective percutaneous coronary intervention (PCI), this study evaluate the health economics of testing and diagnosis for stable coronary artery disease (stable CAD) as long-term longitudinal study.
Basic objectives2	Others
Basic objectives -Others	long-term clinical outcomes and cumulative public medical costs
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint is cost-effectiveness analysis (CEA).
Key secondary outcomes	The secondary endpoints are major adverse coronary events (MACEs) or life years (LYs unit: year) and medical costs. CEA was the ratio of the related medical costs for over 36 months and LYs (US$/LY).

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	This study identified a stable CAD in the subjects for analysis from the database using information including age when treatment was received, main disease (International Classification of Diseases 10th Revision: ICD-10), and treatment history. Out of ICD-10 code I11.0 through I50.9, eligibility criteria included patients with a disease code indicating stable CAD, adults aged 20 years or older, and patients undergoing testing or diagnosis related to the degree of anatomical coronary stenosis or functional ischemia severity for the first time: computed tomography angiography (CTA), stress myocardial perfusion imaging (MPI), coronary angiography (CAG), or coronary fractional flow reserve (FFR). Subjects were followed up for at least 1 year (excluding cases of mortality).
Key exclusion criteria	The exclusion criteria were as follows: prior coronary revascularization, history of ACS within 1 year before the index day, and any latent risk factors that could affect the evaluation of cardiac disease diagnosis and treatment, such as cardiac-related surgery, assisted circulation or arrhythmia device implantation. We also excluded cases thought to have a low risk of cardiac disease. These included patients undergoing CTA alone for whom stress electrocardiogram (ECG) or stress echocardiography had not been performed within 1 year before the index day, patients undergoing CAG alone who had undergone the same testing two or more times (excluding follow-up CAG), and patients not treated with anti-platelet agents within 6 months after CAG (excluding cases considered to have no coronary stenosis). Patients who underwent coronary revascularization within 5 days after the index day were excluded because they were considered to have a very high risk of coronary disease and/or to be high priority emergency cases. Patients with concurrent systemic diseases, including malignant tumors or Kawasaki disease (sequela), as well as general injuries, were excluded because these factors could affect prognosis and medical costs.
Target sample size	3500

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Takura
Organization	The University of Tokyo
Division name	Department of Healthcare Economics and Health Policy, Graduate School of Medicine,
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL	+81-3-5800-9523
Email	ttakura@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Takura
Organization	The University of Tokyo
Division name	Department of Healthcare Economics and Health Policy, Graduate School of Medicine,
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
TEL	+81-3-5800-9523
Homepage URL	http://plaza.umin.ac.jp/hehp/thebd.html
Email	acishea@gmail.com

Sponsor
Institute	Department of Healthcare Economics and Health Policy, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization	The University of Tokyo
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Hospital IRB
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	acishea@gmail.com

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	東京大学附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	3500
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	2019 Year 03 Month 26 Day
Date of IRB	2019 Year 03 Month 26 Day
Anticipated trial start date	2020 Year 01 Month 07 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This retrospective cohort study used a large database obtained from the public medical insurance system of Japan. The data source comprised medical economic big data that mainly included medical service bills gathered from public insurers (health insurance societies of companies and so on) throughout Japan (TheBD). We examined the medical service received at hospitals, clinics, and pharmacies between April 2012 and March 2019 based on therapy performed (testing/diagnosis, pharmacotherapy, treatment/surgery, hospitalized recuperation, and so on), outcomes (death, hospital transfer, and so on), and medical costs and chronologically linked subjects with unified IDs. An analysis of related testing combinations was performed after dividing subjects into groups depending on whether or not functional myocardial ischemia was evaluated and considering the degree of invasiveness. Specifically, we broadly divided subjects into the anatomical and functional evaluation groups and also categorized subjects according to whether they entered the catheterization laboratory. Subjects were divided into the following groups according to the modality: those who only underwent CTA, those who underwent only CAG or, in some cases, CAG and CTA, those who underwent only MPI or, in some cases, MPI and CTA, and a those who underwent either CAG and FFR or MPI and CAG. The bias related to patient backgrounds was reduced as much as possible using propensity score. For PS, we applied a multiple logistic regression analysis model using backward stepwise regression to predict dependent factors with functional ischemia evaluation being performed described as 1 and not being performed described as 0. To identify explanatory factors (covariance), we calculated PS for each case as sex, age/disease/pharmacotherapy/risk factors and matched the sample size with greedy matching. We then confirmed data distribution and balance for both groups (detailed testing of summary statistics per group).

Management information
Registered date	2020 Year 05 Month 01 Day
Last modified on	2020 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045959

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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