UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051758 |
|---|---|
| Receipt number | R000059071 |
| Scientific Title | A prospective study on the learning curve in the analysis of FFR angiography |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/07/31 10:33:52 |
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Basic information
Public title
A prospective study on the learning curve in the analysis of FFR angiography
Acronym
A prospective study on the learning curve in the analysis of FFR angiography
Scientific Title
A prospective study on the learning curve in the analysis of FFR angiography
Scientific Title:Acronym
A prospective study on the learning curve in the analysis of FFR angiography
Region
| Japan |
Condition
Condition
Patients with suspected ischemic heart disease and planned coronary angiography
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the learning curve required for FFR angio analysis as the primary endpoint, and evaluate the factors that affect the learning curve as the secondary endpoint.
Basic objectives2
Others
Basic objectives -Others
learning curve
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Learning curve required for FFR angio analysis
Key secondary outcomes
Factors affecting the learning curve
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
FFR anngio
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with suspected ischemic heart disease scheduled for coronary angiography
Key exclusion criteria
1) Patients with ST-segment elevation myocardial infarction (STEMI)
2) Patients with bypass surgery, surgical or percutaneous valve replacement, or heart transplant
3)Patients with premature atrial contraction or atrial fibrillation or 2nd or 3rd degree atrioventricular block
4) Excluding dialysis patients Severe renal dysfunction
5) Patients with severe valvular disease
6)Patients under treatment for bronchial asthma or chronic obstructive pulmonary disease
7) Patients with angle-closure glaucoma
8) Patients who are pregnant or may be pregnant
9) In addition, patients who are judged to be inappropriate as subjects by the investigator (subinvestigator)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sasou |
Organization
Mie University Hospital
Division name
Faculty of Clinical Engineering
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-232-1111
ce-sasou@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Sasou |
Organization
Mie University Hospital
Division name
Faculty of Clinical Engineering
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-232-1111
Homepage URL
ce-sasou@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Sasou Takashi
Funding Source
Organization
Mie University Hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital
Address
2-174 Edobashi, Tsu City, Mie
Tel
059-232-1111
ce-sasou@clin.medic.mie-u.ac.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
三重県
Institutions
Institutions
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059071
