UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051520 |
|---|---|
| Receipt number | R000058771 |
| Scientific Title | Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Coronary Microvascular Function and Fractional Flow Reserve in the Multicenter Registry |
| Date of disclosure of the study information | 2023/07/17 |
| Last modified on | 2023/07/17 18:49:56 |
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Basic information
Public title
Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Coronary Microvascular Function and Fractional Flow Reserve in the Multicenter Registry
Acronym
J-ADVANCE Registry
Scientific Title
Clinical Outcomes of Japanese Patients with Coronary Artery Disease Assessed by Coronary Microvascular Function and Fractional Flow Reserve in the Multicenter Registry
Scientific Title:Acronym
J-ADVANCE Registry
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By measuring FFR and coronary microvascular function(CFR and IMR), the present study aims to investigate the incidence and clinical impact of (1) coronary microvascular dysfunction with epicardial coronary artery disease and (2) INOCA (ischemia with non-obstructive coronary artery disease) in real-world practice in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAD arm: 1-year POCE (patient-oriented composite endpoints; a composite of all-cause death, any myocardial infarction, and any revascularization)
INOCA arm: 1-year MACE (major adverse cardiovascular events; a composite of cardiac death, any myocardial infarction, any revascularization, hospitalization due to unstable angina)
Key secondary outcomes
At enrollment
1) Normal values of CFR and IMR in each coronary artery (LAD, LCX, and RCA)
2) Relationship between FFR, angio-based FFR, and coronary microvascular function (CFR and IMR)
3) Frequency of discordant cases between RFR and coronary microvascular function (CFR and IMR) and their associated factors
At 1-year follow-up
4) Improvement in clinical symptoms assessed by the Seattle Angina Questionnaire-7.
5) POCE
6) MACE
7) Heart failure requiring hospitalization
8) Stroke requiring hospitalization
At 3-year follow-up
9) POCE
10) MACE
11) Heart failure requiring hospitalization
12) Stroke requiring hospitalization
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 willing to provide written informed consent
2) Patients over 20 years old
3) Patients undergoing coronary angiography due to clinically suspected coronary artery disease
4) Patients performing FFR and microvascular function (CFR and IMR) measurement with >=50% stenosis by visual estimation on coronary angiography (CAD arm)
5) Patients performing ACH provocation test and FFR and microvascular function (CFR and IMR) measurement with <50% stenosis by visual estimation on coronary angiography (INOCA arm)
Key exclusion criteria
1) Culprit lesions in patients with acute coronary syndrome
2) Graft lesions
3) Patients with congestive heart failure
4) Severe coronary stenosis lesions (>=90% stenosis by visual estimation)
5) Patients with a previous history of PCI and CABG (only INOCA arm)
6) Patients deemed inappropriate for inclusion by the principal investigators
Target sample size
1650
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo Medical University Hachiouji Medical Center
Division name
Cardiology
Zip code
193-0998
Address
Tatemachi1163, Hachiouji , Tokyo
TEL
042-665-5611
n-tanaka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Sapporo Cardio Vascular Clinic
Division name
Cardiovascular Medicine
Zip code
007-0849
Address
North 49, East 16-1, Higashi Ward, Sapporo
TEL
0117847847
Homepage URL
kuramitsu@heart-kizuna.com
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
Nobuhiro Tanaka
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402
Tel
03-3351-6141
j.advance.registry.2022@gmail.com
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
| 2023 | Year | 07 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058771
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
