UMIN-CTR Clinical Trial

Basic information
Public title	Thresholds of invasive physiological indices associated with angina and limited exercise capacity in patients with chronic coronary syndrome
Acronym	SYMPTOM REGISTRY
Scientific Title	Thresholds of invasive physiological indices associated with angina and limited exercise capacity in patients with chronic coronary syndrome
Scientific Title:Acronym	SYMPTOM REGISTRY
Region	Japan

Condition
Condition	chronic coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the thresholds of fractional flow reserve (FFR) and diastolic pressure ratio (dPR) associated with angina or impaired exercise capacity in patients with chronic coronary syndrome (CCS)
Basic objectives2	Others
Basic objectives -Others	To identify the thresholds of FFR and dPR after coronary revascularization associated with improvement of angina or exercise capacity in patients with CCS who undergo percutaneous coronary intervention (PCI)
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1) The thresholds of FFR and dPR associated with angina 2) The thresholds of FFR and dPR associated with limited exercise capacity during 6-minute walk test 3) The thresholds of FFR and dPR after PCI associated with the improvement of angina 4) The thresholds of FFR and dPR after PCI associated with the improvement of exercise capacity 5) The thresholds of the gains of FFR and dPR between pre and post PCI associated with the improvement of angina 6) The thresholds of the gains of FFR and dPR between pre and post PCI associated with the improvement of exercise capacity
Key secondary outcomes	1) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without ischemia 2) RDS score and SAQ score between patients with and without ischemia 3) RDS score and SAQ score between patients with and without angina during 6-minute walk 4) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without ischemia after PCI 5) The distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk between patients with and without significant gains of FFR and dPR after PCI 6) Pre and post-test comparison of the distance, the exercise time before the onset of angina, and the proportion of angina during 6-minute walk in patients who did not undergo PCI 7) RDS score and SAQ score between patients with and without ischemia after PCI 8) The pre and post-PCI comparison of RDS score and SAQ score between patients with and without ischemia after PCI. 9) RDS score and SAQ score between patients with and without significant gains of FFR and dPR after PCI 10) The pre and post-PCI comparison ofRDS score and SAQ score between patients with and without significant gains of FFR and dPR after PCI 11) The pre and post-test comparison of RDS score and SAQ score in patients who did not undergo PCI 12) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and ejection fraction (EF) between patients with and without ischemia 13) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and EF between patients with and without angina during 6-minute walk 14) Serum creatinine, eGFR, hemoglobin, HbA1c, LDL cholesterol, BNP, and EF between patients with and without limited walk distance during 6-minute walk

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 aged 20 years or older at the time of consent acquisition 2. Patients who understand the contents of informed consent by the investigators and sign the consent form written by himself / herself. 3. Patients with chronic coronary syndrome who are judged by the investigators to be indicated for coronary angiography
Key exclusion criteria	1. Patients with left ventricular ejection fraction less than 35% 2. Patients who have a history of coronary artery bypass grafting 3. Patients with unstable hemodynamics 4. Patients with heart failure of NYHA classification III or IV 5. Patients with a limitation in walking due to diseases other than chronic coronary syndrome 6. Patients with severe valvular heart disease 7. Patients on maintenance dialysis 8. Patients with unstable angina and acute myocardial infarction within 1 month
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Tanaka
Organization	Wakayama Medical University
Division name	Department of Cardiovascular Medicine
Zip code	641-8509
Address	811-1 Kimiidera, Wakayama City
TEL	073-447-2300
Email	a-tanaka@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name HIgashioka
Organization	Wakayama Medical University
Division name	Department of Cardiovascular Medicine
Zip code	641-8509
Address	811-1 Kimiidera, Wakayama City
TEL	073-447-2300
Homepage URL
Email	higashio@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	ZEON MEDICAL INC.
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	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama City
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	和歌山県立医科大学（和歌山県）、和歌山ろうさい病院（和歌山県）、新宮市立医療センター（和歌山県）、南和歌山医療センター（和歌山県）、橋本市民病院（和歌山県）、ひだか病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 15 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	Open public recruiting
Date of protocol fixation	2021 Year 11 Month 19 Day
Date of IRB	2022 Year 01 Month 07 Day
Anticipated trial start date	2022 Year 06 Month 15 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study

Management information
Registered date	2022 Year 06 Month 15 Day
Last modified on	2022 Year 06 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054271

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.