UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047254 |
|---|---|
| Receipt number | R000053472 |
| Scientific Title | Identification of Biomarkers and Microbiota Specific for Plaque Erosion and Layered Plaque in Patients with Acute Coronary Syndromes: A prospective OCT study |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2024/09/25 22:04:12 |
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Basic information
Public title
Identification of Biomarkers and Microbiota Specific for Plaque Erosion and Layered Plaque in Patients with Acute Coronary Syndromes: A prospective OCT study
Acronym
Identification of Biomarkers and Microbiota Specific for Plaque Erosion and Layered Plaque in Patients with Acute Coronary Syndromes: A prospective OCT study
Scientific Title
Identification of Biomarkers and Microbiota Specific for Plaque Erosion and Layered Plaque in Patients with Acute Coronary Syndromes: A prospective OCT study
Scientific Title:Acronym
Identification of Biomarkers and Microbiota Specific for Plaque Erosion and Layered Plaque in Patients with Acute Coronary Syndromes: A prospective OCT study
Region
| Japan | North America |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of the study are in patients with acute coronary syndromes (ACS), (1) to identify biomarkers and microbiota specific for plaque erosion to better understand the underlying pathobiology, (2) to identify biomarkers and microbiota specific for layered plaque to better understand the underlying pathobiology, and (3) to identify potential therapeutic targets based on biomarker and microbiome data.
Basic objectives2
Others
Basic objectives -Others
The aims of the study are in patients with acute coronary syndromes (ACS), (1) to identify biomarkers and microbiota specific for plaque erosion to better understand the underlying pathobiology, (2) to identify biomarkers and microbiota specific for layered plaque to better understand the underlying pathobiology, and (3) to identify potential therapeutic targets based on biomarker and microbiome data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical follow-up after one year will be done.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ACS or stable angina pectoris who are undergoing catheterization and suitable for OCT-guided PCI would be eligible. ACS include STEMI, NSTE-ACS, and unstable angina pectoris.
Key exclusion criteria
1) Previous revascularization at the culprit vessel
2) Chronic Kidney Disease (estimated glomerular filtration rate < 30 mL/min per1.73 m2)
3) Cardiogenic shock, or hemodynamic or electrical instability
4) COVID-19 positive or with high suspicion for COVID-19
5) Tortuous vessel
6) Heavily calcified vessel
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taishi, Yoshiyasu |
| Middle name | |
| Last name | Yonetsu, Minami |
Organization
Tokyo Medical and Dental University Medical Hospital
Kitasato University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5231
t-yonetsu.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Yonetsu |
Organization
Tokyo Medical and Dental University Medical Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5231
Homepage URL
t-yonetsu.cvm@tmd.ac.jp
Sponsor or person
Institute
Massachusetts General Hospital
Institute
Department
Personal name
Funding Source
Organization
Massachusetts General Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, Tokyo Medical and Dental University Medical Hospital
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5231
syomu1.adm@tmd.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
東京医科歯科大学病院（東京都）、北里大学病院（神奈川県）、マサチューセッツ総合病院（米国）/Tokyo Medical and Dental University Medical Hospital, Kitasato University Hospital, Massachusetts General Hospital
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 23 | 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
54
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining informed consent, a correspondence chart (list of research subject identification codes) will be prepared to protect the research subject's personal information. In addition to the blood samples collected in normal clinical practice, additional blood samples for biomarkers will be collected (30 ml), and OCT imaging of the target vessel will be performed within the scope of normal clinical practice at the time of PCI. stool samples will be collected for gut microbiota analysis within 7 days after the completion of PCI. Other data such as demographic data, medical history, laboratory data, etc will be collected from the medical record.
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053472
