UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044692 |
|---|---|
| Receipt number | R000050084 |
| Scientific Title | Relationship between instantaneous wave-free ratio and global longitudinal strain in patients with chronic coronary artery syndrome |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/12/30 23:49:03 |
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Basic information
Public title
Relationship between instantaneous wave-free ratio and global longitudinal strain in patients with chronic coronary artery syndrome
Acronym
Relationship between instantaneous wave-free ratio and global longitudinal strain in patients with chronic coronary artery syndrome
Scientific Title
Relationship between instantaneous wave-free ratio and global longitudinal strain in patients with chronic coronary artery syndrome
Scientific Title:Acronym
iFR-GLS study
Region
| Japan |
Condition
Condition
chronic coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether revascularization by percutaneous coronary intervention (PCI) in patients with chronic coronary artery disease improves "global longitudinal strain (GLS)", the left ventricular cardiac function index in myocardial strain analysis.
Basic objectives2
Others
Basic objectives -Others
Clarify the relationship between the iFR value before PCI and GLS before PCI, the day after PCI, and 3 months after PCI
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between iFR and GLS before treatment, and GLS 3 months after revascularization
Key secondary outcomes
Relationship between FFR and GLS
Relationship between cardiovascular events during the follow-up period, peri-procedural myocardial infarction, and GLS
Relationship between iFR and FFR pressure gradient pattern and GLS
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic coronary artery disease who have physiologicaly significant stenosis in the left anterior descending artery
Patients undergoing revascularization treatment with PCI
Key exclusion criteria
Left ventricular ejection fraction is less than 50%
History of anterior myocardial infarction
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Terashita |
Organization
Kita-harima Medical Center
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
675-1392
Address
926-250, Ichiba-machi, Ono-shi, Hyogo Japan
TEL
0794-88-8800
saibaidike@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Terashita |
Organization
Kita-harima Medical Center
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
675-1392
Address
926-250, Ichiba-machi, Ono-shi, Hyogo Japan
TEL
0794-88-8800
Homepage URL
saibaidike@hotmail.com
Sponsor or person
Institute
Kita-harima Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Kita-harima Medical Center Clinical Research ethics committee
Address
926-250, Ichiba-machi, Ono-shi, Hyogo Japan
Tel
0794-88-8800
toshinori_wakao@kitahari-mc.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
| 2021 | Year | 07 | Month | 01 | 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
| Delay expected |
Results Delay Reason
Insufficient number of registered patients
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Major adverse caldiac event (target lesion revascularization, target vessel revascularization, admission due to cardiovascular disease, bleeding event due to BARC 3 or 5, complication related PCI, and cardiovascular death) during observational period.
Management information
Registered date
| 2021 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050084
