UMIN-CTR Clinical Trial

Basic information
Public title	The vascular function and coronary artery findings on prognosis of coronary artery disease
Acronym	The vascular function and coronary artery findings on prognosis of coronary artery disease
Scientific Title	The vascular function and coronary artery findings on prognosis of coronary artery disease
Scientific Title:Acronym	The vascular function and coronary artery findings on prognosis of coronary artery disease
Region	Japan

Condition
Condition	Ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the association between the coronary artery findings and the vascular function as an effect of the exercise therapy in a patient with ischemic heart disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Vascular function 9 months after onset of ischemic heart disease
Key secondary outcomes	1) Degree of coronary artery stenosis 9 months after onset of ischemic heart disease 2) Onset of cardiovascular and heart failure events 3) Changes in lipid markers and CPP 4) Adverse events, subjective symptoms

Base
Study type	Observational

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	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patients who underwent percutaneous coronary angioplasty for ischemic heart disease (2) Men and women aged 20 and over and under 85 (3) Patients who obtained written informed consent sign (4) Patients who can continue exercise therapy
Key exclusion criteria	(1) Patients with stroke less than 3 months after onset or systemic embolism (2) Patients with malignant tumor (patients whose symptoms have not been improved) (3) Patients whose prognosis is expected to be within one year due to other medical conditions (4) Others, patients who the research doctor judged as inappropriate for research
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University
Division name	Division of Cardiovascular Medicine
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7538
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University
Division name	Division of Cardiovascular Medicine
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
TEL	0285-58-7538
Homepage URL
Email	kkario@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
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	Jichi Medical University Hospital Clinical Research Ethics Committee A
Address	3311-1, Yakushiji, Shimotsuke, Tochigi, Japan
Tel	0285-58-8933
Email	rinri@jichi.ac.jp

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	自治医科大学附属病院（栃木県）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 15 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
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	Terminated
Date of protocol fixation	2019 Year 03 Month 18 Day
Date of IRB	2019 Year 03 Month 18 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 12 Month 31 Day

Other

Other related information

Study design: Prospective study Recruitment method of subjects: Patients who underwent percutaneous coronary angioplasty for ischemic heart disease (myocardial infarction, angina pectoris), and all who met the selection criteria Recruitment period: From July 1, 2019 to December 31, 2021 Measurement item: 1) Height, weight, body mass index 2) Blood pressure, pulse rate 3) General blood test 4) Urinalysis 5) 12 lead ECG, chest X-ray, cardiac ultrasound 6) Cardiac catheter findings 7) Home blood pressure data 8) Cardiac rehabilitation data 9) Special blood test (CPP: Calcic protein particle) 10) Arteriosclerosis index (CAVI: cardio-ankle vascular index, PWV: pulse wave velocity, ABI: ankle-brachial index)

Management information
Registered date	2019 Year 04 Month 12 Day
Last modified on	2021 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041521