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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010106
Receipt No. R000011840
Scientific Title Advanced endothelial dysfunction in patients with coexistence of coronary artery disease and peripheral arterial disease - effects of Cilostazol on endothelial dysfunction in peripheral arterial disease -
Date of disclosure of the study information 2013/02/25
Last modified on 2013/07/11

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Basic information
Public title Advanced endothelial dysfunction in patients with coexistence of coronary artery disease and peripheral arterial disease - effects of Cilostazol on endothelial dysfunction in peripheral arterial disease -
Acronym Examination concerning the endothelial function of the patients with coexistence of coronary artery disease and peripheral arterial disease
Scientific Title Advanced endothelial dysfunction in patients with coexistence of coronary artery disease and peripheral arterial disease - effects of Cilostazol on endothelial dysfunction in peripheral arterial disease -
Scientific Title:Acronym Examination concerning the endothelial function of the patients with coexistence of coronary artery disease and peripheral arterial disease
Region
Japan

Condition
Condition The cases with coexistence of coronary artery disease and peripheral arterial disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the endothelial dysfunction assessed by RH-PAT examination might associate with the coexistence of CAD and PAD and to investigate potential therapeutic effects of Cilostazol on PAD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes endothelial evaluation of function by reactive hyperemia peripheral arterial tonometry
Key secondary outcomes The effect of Cilostazol to the peripheral artery disease patients

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
90 years-old >
Gender Male and Female
Key inclusion criteria The coronary artery disease (CAD) patient who has a peripheral artery disease (PAD).
PAD (1)ABI < 0.9 (2)Fontaine classification >= II (3) previous revascularization in lower limbs (4) occlusive arteries in lower limbs by imaging examinations
CAD as the presence of >= 50% narrowing of coronary artery diameter in at least one major coronary artery
Key exclusion criteria (1)heart failure with reduced left ventricular systolic function (ejection fraction<50%) (2)severe valvular heart disease(3)cardiomyopathy (4)systemic illness [including advanced endocrine, hepatic, or renal diseases (5)active inflammatory diseases (6)cancer (7)with residual hemiplegia
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Maeda
Organization Kumamoto University Faculty of Life Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto University Faculty of Life Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City
TEL
Homepage URL
Email

Sponsor
Institute Department of Cardiovascular Medicine, Faculty of Sciences, Kumamoto University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Jinnouchi Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 02 Month 25 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
2006 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information There is a possibility of the endotherial dysfunction in patients with coexistence of coronary artery disease and peripheral arterial disease.

Management information
Registered date
2013 Year 02 Month 24 Day
Last modified on
2013 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011840

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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