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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012453
Receipt No. R000014574
Scientific Title Incremental Prognostic Value of Late Gadolinium Enhanced Magnetic Resonance Imaging on SYNTAX Score in Patients with Stable Coronary Artery Disease
Date of disclosure of the study information 2013/12/01
Last modified on 2016/08/19

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Basic information
Public title Incremental Prognostic Value of Late Gadolinium Enhanced Magnetic Resonance Imaging on SYNTAX Score in Patients with Stable Coronary Artery Disease
Acronym Incremental Prognostic Value of Late Gadolinium Enhanced Magnetic Resonance Imaging on SYNTAX Score in Patients with Stable Coronary Artery Disease
Scientific Title Incremental Prognostic Value of Late Gadolinium Enhanced Magnetic Resonance Imaging on SYNTAX Score in Patients with Stable Coronary Artery Disease
Scientific Title:Acronym Incremental Prognostic Value of Late Gadolinium Enhanced Magnetic Resonance Imaging on SYNTAX Score in Patients with Stable Coronary Artery Disease
Region
Japan

Condition
Condition Stable coronary artery disease
Classification by specialty
Medicine in general Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to assess the incremental prognostic value of late gadolinium enhanced MRI (LGE-MRI) on SYNTAX score in CAD patients.
Basic objectives2 Others
Basic objectives -Others Evaluation of prognostic value of MRI
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major outcome was incidence of cardiovascular events including cardiovascular death, nonfatal myocardial infarction, unstable angina, ischemic stroke, coronary revascularization, re-hospitalization for heart failure.
Key secondary outcomes

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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with stable coronary artery disease
Key exclusion criteria Contraindication to MRI
Severe renal dysfunction (eGFR<30ml/kg/1.73m2)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Kato
Organization Kanagawa Cardiovascular and respiratory Center
Division name Department of Cardiology
Zip code
Address 6-16-1, Tomiokahigashi, Kanazawaku, Yokohama, Kanagawa
TEL 045-701-9581
Email shingo.m12226@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Kato
Organization Kanagawa Cardiovascular and respiratory Center
Division name Department of Cardiology
Zip code
Address 6-16-1, Tomiokahigashi, Kanazawaku, Yokohama, Kanagawa
TEL 045-701-9581
Homepage URL
Email shingo.m12226@gmail.com

Sponsor
Institute Kanagawa Cardiovascular and respiratory 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
Address
Tel
Email

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
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information After the acquisition of late gadolinium enhanced MRI, we perform clinical follow up. We will assess the incremental prognostic value of late gadolinium enhanced MRI on SYNTAX score in CAD patients.

Management information
Registered date
2013 Year 12 Month 01 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014574

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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