UMIN-CTR Clinical Trial

Basic information
Public title	Histopathological Characterization of High-Intensity Signals in Coronary Plaques on Noncontrast T1-Weighted Magnetic Resonance Imaging
Acronym	HIP vs. non-HIP on histopathology
Scientific Title	Histopathological Characterization of High-Intensity Signals in Coronary Plaques on Noncontrast T1-Weighted Magnetic Resonance Imaging
Scientific Title:Acronym	HIP vs. non-HIP on histopathology
Region	Japan

Condition
Condition	ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In a previous study that investigated the presence of coronary high intensity plaque (HIP) detected by non-contrast T1-weighted imaging (T1WI), the signal intensity of coronary plaque-to-cardiac muscle ratio (PMR) >1.0 was associated with coronary events. This study aimed to investigate the histopathological characteristics of HIPs in the coronary artery.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological observations between HIP and non-HIP groups.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	All patients with significant coronary stenosis (>70%) in the vessels that were large enough to perform directional coronary atherectomy (DCA) on computed tomography angiography or coronary angiography were enrolled in the study.
Key exclusion criteria	(1)Acute myocardial infarction (2)Cardiac shock (3)Serum creatinine >2.0mg/dL (4)Patients who cannot undergo MRI (5)Patients expected to die within 1 year with malignant disease
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Sawada
Organization	Himeji Cardiovascular Center
Division name	Cardiology
Zip code	6700981
Address	520 kou saijo Himeji Hyogo Japan
TEL	0792933131
Email	kenzouzu@gmail.com

Public contact
Name of contact person	1st name KENZO Middle name Last name UZU
Organization	Himeji Cardiovascular center
Division name	Cardiology
Zip code	670-0981
Address	520 kou saijo Himeji Hyogo Japan
TEL	0792933131
Homepage URL
Email	kenzouzu@gmail.com

Sponsor
Institute	Himeji Cardiovascular center
Institute
Department

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Surgical Pathology, Hyogo College of Medicine, Nishinomiya, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Himeji Cardiovascular center
Address	520 kou saijo Himeji Hyogo Japan
Tel	0792933131
Email	kenzouzu@gmail.com

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	2020 Year 01 Month 13 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	52
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	2017 Year 08 Month 17 Day
Date of IRB	2017 Year 09 Month 04 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

First, the lesion is evaluated by cardiac MRI, and the lesion is divided into two groups, HIP and non-HIP group. Within 30 days after cardiac MRI, the lesion is treated with catheterization using directional coronary athrectomy, and the plaques are collected. The collected plaques are fixed in formalin, and deliver to the Department of Pathology, Hyogo College of Medicine with anonymized. All plaques are pathologicaly evaluated without patient'data. The obtained pathological data is analyzed at the Himeji Cardiovascular Center.

Management information
Registered date	2020 Year 01 Month 13 Day
Last modified on	2020 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044641