UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025089 |
|---|---|
| Receipt number | R000028641 |
| Scientific Title | The Comparison of Diagnostic Performance of Fractional Flow Reserve between the use of 4 Fr and 6 Fr catheters in Intermediate Coronary Artery Stenosis |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2020/11/12 11:00:13 |
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Basic information
Public title
The Comparison of Diagnostic Performance of Fractional Flow Reserve between the use of 4 Fr and 6 Fr catheters in Intermediate Coronary Artery Stenosis
Acronym
COmparison of Fractional Flow Reserve Measurements through 4 FrEnch versus 6 FrEnch Diagnostic Catheter - COFFEE trial -
Scientific Title
The Comparison of Diagnostic Performance of Fractional Flow Reserve between the use of 4 Fr and 6 Fr catheters in Intermediate Coronary Artery Stenosis
Scientific Title:Acronym
COmparison of Fractional Flow Reserve Measurements through 4 FrEnch versus 6 FrEnch Diagnostic Catheter - COFFEE trial -
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the efficacy of FFR measurement using 4Fr diagnostic catheters
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of FFR value measured by 4Fr and 6Fr catheters
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are indicated for coronary angiography or coronary intervention.
2) Patients with more than 50% stenosis in main coronary artery
3) Patients with indicated FFR value (more than 0.70, less than 0.90), measured by 4Fr diagnostic catheter
Key exclusion criteria
1) Patients who are contraindicated to adenosine
2) Patients who have bronchial asthma
3) Patients who have a second degree of AV block or third degree of AV block.
4) Patients who have hemodialysis
5) Patients who have severe renal dysfunction (Crea; more than 2.0mg/dL)
6) Inadequate lesion for FFR measurement
7) Patients with unstable hemodynamic conditions
8) Patients with LVEF less than 30%
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Futoshi Yamanaka |
Organization
Shonankamakura General Hospital
Division name
Department of Cardiology and Catheterization Laboratory
Zip code
Address
1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL
0467-46-1717
futoshi-yamanaka@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Moriyama |
Organization
Shonankamakura General Hospital
Division name
Department of Cardiology and Catheterization Laboratory
Zip code
Address
1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL
0467-46-1717
Homepage URL
e2718nm@gmail.com
Sponsor or person
Institute
Shonankamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonankamakura General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 30 | 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
| 2016 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no special instruction
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028641
