UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015906 |
|---|---|
| Receipt number | R000018333 |
| Scientific Title | Diagnostic accuracy of diastolic fractional flow reserve (d-FFR) for functional evaluation of coronary stenosis |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2020/10/08 11:56:32 |
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Basic information
Public title
Diagnostic accuracy of diastolic fractional flow reserve (d-FFR) for functional evaluation of coronary stenosis
Acronym
DIASTOLE Study
Scientific Title
Diagnostic accuracy of diastolic fractional flow reserve (d-FFR) for functional evaluation of coronary stenosis
Scientific Title:Acronym
DIASTOLE Study
Region
| Japan |
Condition
Condition
Stable coronary disease with a single major coronary artery lesion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare diagnosis accuracy rate of diastolic FFR (d-FFR) and conventional full cardiac cycle FFR to scintigraphy for a single major coronary vessel lesion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of the accuracy rate from the d-FFR and full cardiac cycle FFR using myocardial scintigraphy as a golden standard
Key secondary outcomes
1) The cutoff value of d-FFR and FFR using myocardial scintigraphy as a golden standard
2) Assess the sensitivity and the specificity, the positive-predictive value, the negative-predictive value of diastolic Pd/Pa at rest and Pd/Pa at rest using myocardial scintigraphy as a golden standard
3) The cutoff value of diastolic Pd/Pa at rest and Pd/Pa at rest using myocardial scintigraphy as a golden standard
4) Assess the sensitivity and the specificity, the positive-predictive value, the negative-predictive value of myocardial scintigraphy using FFR as a golden standard
5) Assess the sensitivity and the specificity, the positive-predictive value, the negative-predictive value of myocardial scintigraphy using d-FFR as a golden standard
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) Patient who is adaptable to coronary angiography (CAG) or coronary revascularization (PCI/CABG)
2) Patient who has stable coronary artery disease with more than 50% diameter stenosis in a single major coronary artery on CAG by visual estimation
3) Age>=20 years old at time of getting informed consent
4) Patient who can understand and voluntarily sign the informed consent form
Key exclusion criteria
1) Patient who has left main trunk lesion
2) Chronic total occlusion (CTO) lesion
3) lesion that is in-stent restenosis
4) Patient who has multivessel coronary artery disease
5) Patient who is diagnosed with ST-segment elevation acute myocardial infarction
6) Culprit lesion of non ST-segment elevation acute coronary syndrome
7) Patient who has anamnesis of old myocardial infarction
8) Patient who meets a contraindication of ATP (Adenosine triphosphate disodium hydrate)
9) Patient with frequent ventricular extrasystole, and with atrial/auricular flutter or fibrillation
10) Patient who is diagnosed left heart failure or altitude valvular disease
11) Patient with a history of coronary artery bypass graft (CABG)
12) Patient with severe renal dysfunction (eGFR < 30mL/min/1.73m2)
13) Patient who doesn't agree to provide the informed consent
14) Patient is concluded unsuitable by a docter in charge of the present clinical research
Target sample size
413
Research contact person
Name of lead principal investigator
| 1st name | Akasaka |
| Middle name | |
| Last name | Takashi |
Organization
Wakayama Medical University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
TEL
073-447-2300
akasat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takayama |
| Middle name | |
| Last name | Hiroki |
Organization
The study secretariat of DIASTOLE Study
Division name
Soiken Inc.
Zip code
101-0052
Address
NFB Ogawa-cho Bldg 4F, 1-3-1, Kanda Ogawa-cho, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
NPO Association for Thinking about the Future of the Heart Angioplasty
Institute
Department
Personal name
Funding Source
Organization
NPO Association for Thinking about the Future of the Heart Angioplasty
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama
Tel
073-447-2300
wa-rinri@wakayama-med.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 10 | 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
| 2014 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
* Prospective, multicenter
* From 2014/9/1 to 2020/8/31
* Enrollment: Until 2020/2/28
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2020 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018333
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