UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051134 |
|---|---|
| Receipt number | R000058316 |
| Scientific Title | Diagnostic accuracy of Murray law based quantitative flow ratio in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/05/23 11:15:57 |
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Basic information
Public title
Diagnostic accuracy of Murray law based quantitative flow ratio in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement
Acronym
Diagnostic accuracy of Murray law based quantitative flow ratio in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement
Scientific Title
Diagnostic accuracy of Murray law based quantitative flow ratio in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement
Scientific Title:Acronym
Diagnostic accuracy of Murray law based quantitative flow ratio in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement
Region
| Japan |
Condition
Condition
Aortic stenosis, coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the accuracy of pre-TAVR murray based law quantitative flow ratio as a diagnostic tool for coronary artery lesions, using post-TAVR FFR < 0.8 as the reference standard for identifying ischemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study was the diagnostic performance of pre-TAVR murray based law quantitative flow ratio without nitroglycerin. Post-TAVR invasive FFR < 0.8 was used as a reference standard of ischemia.
Key secondary outcomes
The secondary endpoints were the diagnostic performance of pre- and post-TAVR iFR, pre-TAVR QFR, and post-TAVR murray based law quantitative flow ratio.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 patients with moderate or greater (30-90%) stenotic lesions on gross evaluation using coronary CT angiography and coronary angiography prior to TAVR.
2 patients aged > 20 years at the time of diagnosis.
Key exclusion criteria
1. Patients with hemodynamic instability
2. History of acute myocardial infarction within two months
3. Patients with major procedural complications, such as death, brain stroke, acute myocardial infarction with the exception of permanent pacemaker implantation.
4. Patients who underwent percutaneous coronary angioplasty or coronary artery bypass grafting for severe coronary artery stenosis during perioperative TAVR.
5. Patients with metal stent implanted in the left main trunk
6. Patients with left main trunk stenosis > 30% and one or more metal stents implanted in the left coronary artery.
7. Patients with more than one coronary artery with a metal stent
8. Patients who underwent coronary artery bypass grafting
9. Patients with chronic total occlusion in any of the major coronary arteries on coronary angiography
10. Patients with artifacts or contrast defects severe enough to interfere with coronary CT angiography were deemed unreadable by institutional evaluation.
11. Patients in whom it was expected to have anatomical difficulty in passing wires through the coronary arteries.
12. Patients who refused to participate in the study
13. In other cases, the investigator determined that the participant was inappropriate for the study.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ohtake |
Organization
Kobe University Hospital, School of Medicine
Division name
Department of Coronary Artery Disease
Zip code
650-0017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe-shi, Hyogo
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Ohtake |
Organization
Kobe University Hospital, School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
650-0017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe-shi, Hyogo
TEL
078-382-5846
Homepage URL
hotake@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
no organization
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
Secretariat of Medical Ethics Committee (Observational Research), Division of Research Ethics, Center for Clinical Research Promotion, Kobe University Hospital
Address
5-2, Kusunokucho 7-chome, Chuo, Kobe, Hyogo
Tel
0783825111
kansatsu@med.kobe-u.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
| 2023 | Year | 05 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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 | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058316
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