UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034588 |
|---|---|
| Receipt number | R000039419 |
| Scientific Title | Detection of Ruptured plaques as Embolic source in Aorta to clarify the Mechanism of systemic organ deterioration by Non-Obstructive General Angioscopy |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/04/19 16:15:01 |
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Basic information
Public title
Detection of Ruptured plaques as Embolic source in Aorta to clarify the Mechanism of systemic organ deterioration by Non-Obstructive General Angioscopy
Acronym
Relationship between aortic plaques and organ insufficiency: DREAM NOGA study
Scientific Title
Detection of Ruptured plaques as Embolic source in Aorta to clarify the Mechanism of systemic organ deterioration by Non-Obstructive General Angioscopy
Scientific Title:Acronym
Relationship between aortic plaques and organ insufficiency: DREAM NOGA study
Region
| Japan |
Condition
Condition
coronary artery disease or suspected
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the frequency and quality of aortic plaques with non-obstructive general angioscopy and organ insufficiency such as brain, kidney, and peripheral artery.
Basic objectives2
Others
Basic objectives -Others
Multicenter, prospective, observational registory
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.the relationship between the quality of aortic plaques and the increase of cerebral infarction with MRI
2.the relationship between the quality of aortic plaques and the increase of urinary albumin creatinin ratio
3.the relationship between the quality of aortic plaques and the change of ABI value and sarcopenia score
4.the relationship between aortic plaques and the occurrence of acute aortic dissection
Key secondary outcomes
1.the relationship between the frequency of aortic plaques and the increase of cerebral infarction with MRI
2.the relationship between the frequency of aortic plaques and the increase of urinary albumin creatinin ratio
3.the relationship between the frequency of aortic plaques and the change of ABI value
4.comparison of aortic plaque findings between non-obstructive general angioscopy and aortic CT
5.the comparison between coronary and aortic plaque findings with non-obstructive general angioscopy
6.the progression of aortic plaques
7.the relationship between aortic plaque and influence factors
8.the relationship between aortic plaque and brain atrophy with MRI
9.the relationship between aortic plaque and atherosclerosis with brain MRI
10.the relationship between aortic plaque and dementia score
11.the relationship between aortic plaque and carotid duplex ultrasound findings
12.the relationship between aortic plaque and SPP score
13.the relationship between aortic plaque and sarcopenia score
14.the frequency of occurrence of complication with non-obstructive general angioscopy during and 48 hours after the procedure
15.the relationships aortic plaques and clinical events
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patient who received CAG or PCI with confirmed or suspected of cardiovascular disease underwent
2) patient who received non-obstructive general angioscopy
3) Patients who clinically have high risk of occurrence of aortic disease and aortic CT examination is useful for patients
4) Patients who clinically have high risk of occurrence of cerebral infarction and brain MRI is useful for patients
high risk of occurrence of cerebral infarction was defined as 1) neurological symptom, 2)atherosclerotic factors, and aortic calcification with Xray or CT
5) >= 20 years old, male and female
6) written informed consent
Key exclusion criteria
1) anaphylactic shock by contrast medium
2) metal in the body
3) Claustrophobia
4) pregnancy or breast-feeding
5) cardiogenic shock
6) acute aortic dissection or rupture of aortic aneurysm, or impending state of them
7) appropriate patients decided by the doctor
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hirayama |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi-kamicho, itabashi-ku, Tokyo
TEL
03-3972-8111
atsushi-hirayama@oph.gr.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hirayama |
Organization
Nihon University School of Medicine, Division of Cardiology
Division name
Division of Cardiology, Department of Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
atsushi-hirayama@oph.gr.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital Clinical Research Center
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.ac.jp
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
| 2018 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Relationship between aortic plaques with non-obstructive general angioscopy and organ insufficiency
Management information
Registered date
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039419
