UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040282 |
|---|---|
| Receipt number | R000045959 |
| Scientific Title | Health economics-based verification of functional myocardial ischemia evaluation of stable coronary artery disease |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/05/01 14:06:12 |
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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
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
acishea@gmail.com
Sponsor or person
Institute
Department of Healthcare Economics and Health Policy, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045959
