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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005898
Receipt No. R000005905
Scientific Title The impact of fractional flow reserve in left anterior descending
Date of disclosure of the study information 2011/07/01
Last modified on 2015/04/27

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Basic information
Public title The impact of fractional flow reserve in left anterior descending
Acronym The impact of fractional flow reserve in left anterior descending
Scientific Title The impact of fractional flow reserve in left anterior descending
Scientific Title:Acronym The impact of fractional flow reserve in left anterior descending
Region
Japan

Condition
Condition the patients performed coronary angiography without coronary stenosis in LAD
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 decrease of FFR value in normal looking LAD is associated with myocardial area maintained by LAD lesion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the comparison of pullback pressure in LAD, pullback FFR in LAD, plaque volume
Key secondary outcomes LV mass, Myocardial oxygen uptake(AIV and Coronary sinus)

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)the patients undergone coronary angiografy without coronary stenosis in LAD
2)Patients providing written consent for participattion in this clinical trial on their own volition after receiving a thorough explanation of the study
Key exclusion criteria 1)patients have coronary stenosis in LAD
2)patients on hemodialysis
3)patients with acute coronary syndorome
4)patients with diabetes mellitus
5)patients with cardiomyopathy
6)patients with heart failer
7)patients with aortic valve disease
8) Patients who are judged by the principal investigator to be ineligible for enrollment in the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL 0798-45-6553
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fukunaga
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL 0798456553
Homepage URL
Email

Sponsor
Institute Cardiovascular Division, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine Division of Cardiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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 1)We measure the pressure from most distal to proximal vessel in LAD, and FFR value.
2)We measure the plaque volume in LAD by intravascular ultrasound.
3)We measure the oxygen uptake. Myocardial oxygen uptake equals arterial oxygen content - coronary sinus oxygen content.
4)We check the LV mass by MRI.

Management information
Registered date
2011 Year 06 Month 30 Day
Last modified on
2015 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005905

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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