UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010106 |
|---|---|
| Receipt number | 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 02:55:11 |
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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
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
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011840
