UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029745 |
|---|---|
| Receipt number | R000033981 |
| Scientific Title | Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy in Patients with COronary Heart Disease |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2017/10/28 22:38:38 |
* 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
Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy in Patients with COronary Heart Disease
Acronym
Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy
Scientific Title
Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy in Patients with COronary Heart Disease
Scientific Title:Acronym
Detecting Aortic Atherosclerosis by Non-obstructive Angioscopy
Region
| Japan |
Condition
Condition
Coronary heart disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect the incidence of aortic plaque, to detect the variety of aortic plaque, and examine the relationship between aortic and coronary plaque
Basic objectives2
Others
Basic objectives -Others
observational, cross-sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
acute aortic syndrome and atheromatous embolization
Key secondary outcomes
The incidence, location, and the degree of ruptured aortic plaques detected by non-obstructive angioscopy
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
patients who underwent diagnostic coronary angiography (CAG) or elective percutaneous coronary intervention (PCI) with non-obstructive angioscopy
Key exclusion criteria
use of intra-aortic balloon pumping or percutaneous cardiopulmonary support, hemodynamic instability (i.e., Killip state >2 or cardiogenic shock), known aortic dissection, aortic aneurysm larger than the size indicated for surgery, (thoracic diameter >=6 mm or abdominal diameter >=5 mm), allergy to contrast media, and pregnancy.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kauzhisa Kodama, MD, PhD |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
Address
5-4-8, Nishi-Kujo, Konohana, Osaka
TEL
06-6462-0261
ascopy_kdm@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sei Komatsu, MD, PhD |
Organization
Osaka Gyoumeikan Hospital
Division name
Cardiovascular Center
Zip code
Address
5-4-8, Nishi-Kujo, Konohana, 554-0012, Osaka
TEL
06-6462-0261
Homepage URL
plaquemap@yahoo.co.jp
Sponsor or person
Institute
Cardiovascular Center, Osaka Gyoumeikan Hospital
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Center, Osaka Gyoumeikan Hospital
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
大阪暁明館病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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
To identify the incidence of spontaneous aortic plaque rupture, the components of spontaneous aortic plaque rupture and the dimension and pathologic findings of each component by direct sampling using NOA system.
To analyze the relationship between the details of aortic plaque rupture and patients' characteristics, CT findings, MRI findings, echo findings, and coronary plaque detected by intravascular ultrasound, OCT, and angioscopy and pathological findings.
Management information
Registered date
| 2017 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033981
