UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012453 |
|---|---|
| Receipt number | 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 17:57:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shingo.m12226@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and respiratory 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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014574
