UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048065 |
|---|---|
| Receipt number | R000054271 |
| Scientific Title | Thresholds of invasive physiological indices associated with angina and limited exercise capacity in patients with chronic coronary syndrome |
| Date of disclosure of the study information | 2022/06/15 |
| Last modified on | 2022/12/15 14:23:51 |
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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
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
higashio@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
| 2024 | 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 | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054271
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| Registered date | File name |
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| Registered date | File name |
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