UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of myocardial triglyceride content assessed on 1H-Magnetic Resonance Spectroscopy in subjects with cardiovascular risk
Title of the study (Brief title)	Evaluation of myocardial triglyceride content assessed on 1H-Magnetic Resonance Spectroscopy in subjects with cardiovascular risk
Region	Japan

Condition
Condition	Hypertension, Dyslipidemia, Diabetes Mellitus, Obesity, Sleep apnea syndrome, Coronary artery disease, Chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of myocardial triglyceride content assessed on 1H-Magnetic Resonance Spectroscopy in subjects with cardiovascular risk and cardiac disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the association between myocardial triglyceride content and clinical parameters in subjects with cardiovascular risk and cardiac disease
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients provided written informed consent 2.Patients with presence of clinical or subclinical cardiovascular disease or at least one cardiovascular disease risk factors 1)Serum levels of triglyceride >= 150mg/dl or HDL-C < 40mg/dl 2)Systolic blood pressure >= 130mmHg or diastolic blood pressure >= 85mmHg 3)Plasma levels of fasting blood suger >= 110mg/dl 4)Body mass index >= 25kg/square meter 5)Apnea-hypopnea index >= 5 3.Patients with history of caridac disease 4.Patients with history of coronary artery disease
Key exclusion criteria	1)Patients with contraindication of MRI 2)Patients who judged as ineligible by clinical staffs
Target sample size	150

Research contact person
Name of lead principal investigator	Kazunori Shimada
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email	shimakaz@juntendo.ac.jp

Public contact
Name of contact person	Makoto Hiki
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Homepage URL
Email	m-hiki@juntendo.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 11 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 17 Day
Anticipated trial start date	2016 Year 06 Month 17 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	ongoing

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2018 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026401