UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022401 |
|---|---|
| Receipt number | R000025814 |
| Scientific Title | Microvascular dysfunction in patients with valvular heart disease |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2016/12/26 11:33:53 |
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Basic information
Public title
Microvascular dysfunction in patients with valvular heart disease
Acronym
Microvascular dysfunction in patients with valvular heart disease
Scientific Title
Microvascular dysfunction in patients with valvular heart disease
Scientific Title:Acronym
Microvascular dysfunction in patients with valvular heart disease
Region
| Japan |
Condition
Condition
Valvular heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate coronary microvascular function in patients with valvular heart disease.
Basic objectives2
Others
Basic objectives -Others
To assess the association of microvascular function with biomakers, hemodynamics, echocardiographic findings and patient outcome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluating the differences in the index of microcirculatory resistance (IMR) between patients with valvular heart disease (VHD group) and those without valvular heart disease (Non-VHD group)
Key secondary outcomes
Evaluating the differences in coronary flow reserve (CFR) and fractional flow reserve (FFR) between VHD group and Non-VHD group
Comparing the number of abnormal IMR and abnormal CFR between VHD group and Non-VHD group
Evaluating the relationship between IMR, CFR and FFR and the findings on cardiac catheterization and echocardiography
Evaluating the relationship between IMR, CFR and FFR and clinical events
Comparison of coronary physiological measurements (IMR, CFR and FFR) between groups divided according to ejection fractions or types of valvular heart disease (i.e. aortic stenosis, aortic regurgitation, mitral stenosis and mitral regurgitation)
Evaluating the relationship between RHI and coronary physiological measurements (IMR, CFR and FFR) in the VHD group and non-VHD group.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Cardiac catheterization study and mesurement of coronary microvascular function using Certus Pressure Wire for VHD and non-VHD patients
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically stable patients with valvular heart disease who are undergoing cardiac catheterization
20 years of age or older
Patients who have signed consent forms
Key exclusion criteria
Significant stenosis in the left anterior descending artery (LAD), prior myocardial infarction in the LAD territory, acute decompensated heart failure, acute coronary syndrome, pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
tnishi@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nishi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
tnishi@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 22 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025814
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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