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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036480
Receipt No. R000041521
Scientific Title The vascular function and coronary artery findings on prognosis of coronary artery disease
Date of disclosure of the study information 2019/04/15
Last modified on 2019/06/04

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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 Enrolling by invitation
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
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 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
2019 Year 06 Month 04 Day


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

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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