UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Microvascular dysfunction in patients with valvular heart disease
Title of the study (Brief title)	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	Yoshio Kobayashi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Email	tnishi@chiba-u.jp

Public contact
Name of contact person	Takeshi Nishi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	tnishi@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025814