UMIN-CTR Clinical Trial

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
Email	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
Email	takayama@soiken.com

Sponsor
Institute	NPO Association for Thinking about the Future of the Heart Angioplasty
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018333