UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005898 |
|---|---|
| Receipt number | 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 11:49:43 |
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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
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
Sponsor or person
Institute
Cardiovascular Division, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005905
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
