UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003567 |
|---|---|
| Receipt number | R000004309 |
| Scientific Title | Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey) |
| Date of disclosure of the study information | 2010/05/05 |
| Last modified on | 2014/08/15 21:32:44 |
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Basic information
Public title
Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey)
Acronym
Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey)
Scientific Title
Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey)
Scientific Title:Acronym
Attempts at plaque vulnerability quantification with magnetic resonance imaging using non-contrast T1-weighted technique pilot study (AQUAMARINE Pilot Survey)
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between plaque signal intensity detected by MRI and coronary risk factors(LDL-C, hs-CRP). In addition, the objectives of this study are to verify the hypothesis that plaque signal intensity is changed by aggressive lipid lowering encouraged in some guidelines(AHA/ACC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of coronary plaque signal intensity detected by MRI.
Key secondary outcomes
1. Correlation between baseline
characteristics and coronary plaque
signal intensity detected by MRI or
MDCT.
2. Change from baseline to follow-up
plaque density and area of plaque
detected by MDCT.
3. Correlation between change in plaque
signal intensity detected by MRI and
change in plaque density or plaque volume detected by MDCT.
4. Correlation between change in plaque
signal intensity detected by MRI and
change in blood biomarkers.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lipid-lowering therapy with strong-statin(pitavastatin, atorvastatin, or rosuvastatin) for a period of 12 months to achieve LDL-C<80mg/dL
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with coronary artery disease who have coronary plaque detected by MDCT.
2. Patients aged 20 and over.
3. Patients giving written consent on their own volition for participation in this clinical trial after being provided with sufficient explanation about the study.
Key exclusion criteria
1. Patients scheduled to undergo PCI for evaluation of plaque during the treatment period.
2. Patients who had received PCI on the index lesion in the past where further evaluation of coronary plaque is planned.
3. Patients scheduled to undergo CABG during the treatment period.
4. Patients being treated with lipid-lowering agents(statins, fibrates, probucol, niacin, anion exchange resin, EPA, dextran sulfate sodium, and ezetimibe).
5. Patients who have allergy to pitavastatin, atorvastatin , or rosuvastatin.
6. Patients on cyclosporine therapy, and patients with liver dysfunction (AST or ALT values of >=100IU) or the following diseases considered to be associated with biliary obstruction and/or impaired hepatic function:
acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus.
7. Pregnant or possibly pregnant women, lactating women
8. Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or dialysis patients
9. Patients who are judged by the investigator to be not eligible for enrollment in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Goto |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of cardiology, Department of Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
ygoto@hsp.ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruo Noguchi |
Organization
National Cerebral and Cardiovascular Center
Division name
Division of Cardiology, Department of Medicine
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
tnoguchi@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shin-Koga Hospital, Koga Hospital 21,
Hyogo Brain and Heart Center
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
国立循環器病研究センター（大阪府）、新古賀病院（福岡県）、古賀病院21（福岡県）、
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 05 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 05 | Day |
Last modified on
| 2014 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004309
