UMIN-CTR Clinical Trial

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

stable coronary artery disease

Classification by specialty

Cardiology

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

The University of Tokyo

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Hospital IRB

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

acishea@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学附属病院

Date of disclosure of the study information

2020

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

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