UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026325 |
|---|---|
| Receipt number | R000030239 |
| Scientific Title | Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2021/11/07 20:58:11 |
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Basic information
Public title
Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Acronym
Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Scientific Title
Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Scientific Title:Acronym
Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Basic objectives2
Others
Basic objectives -Others
Physiological assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between the difference in intraluminal intensity of blood speckle (Delta IBS) and fractional flow reserve (FFR) with or without hyperemia.
Key secondary outcomes
1) Comparison between Delta IBS and instantaneous wave-free ratio (iFR) with or without hyperemia.
2) Diagnostic Accuracy of Delta IBS for physiological assessment of coronary artery stenosis by FFR with or without hyperemia.
3) Diagnostic Accuracy of Delta IBS for physiological assessment of coronary artery stenosis by iFR with or without hyperemia.
4) Diagnostic Accuracy of minimum lumen area (MLA) on intravascular ultrasound (IVUS) for physiological assessment of coronary artery stenosis.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
IVUS data acquisition and FFR measurement during percutaneous coronary intervention (PCI).
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
Patients who scheduled to undergo PCI.
Key exclusion criteria
1) Patients with hemodialysis
2) Patients who use nhaled drugs or theophylline products for bronchial asthma
3) Patients with left main trunk lelsion or stenosis >50% at the distal to the target lesion.
4) Patients with chronic total obstruction
5) Patients with severe heart failure (ejection fraction <30% or NYHA >class 3)
6) Patients with prior coronary artery bypass grafting
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Kobayashi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
a-tamiya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
260-0856
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
policemaccho@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-222-7171
takeshis@faculty.chiba-u.jp
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
| 2017 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 27 | Day |
Last modified on
| 2021 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030239
