UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036480 |
|---|---|
| Receipt number | 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 | 2021/03/17 16:53:50 |
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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
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
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041521
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
