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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044692
Receipt No. 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 2021/06/28

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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
Email 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
Email saibaidike@hotmail.com

Sponsor
Institute Kita-harima Medical Center
Institute
Department

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
Email 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
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
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
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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