UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055926 |
|---|---|
| Receipt number | R000063146 |
| Scientific Title | Understanding development and repair of cardiovascular disease mediated by microbiome and mental stress |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2025/02/27 15:12:46 |
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Basic information
Public title
A prospective observational study to examine the role of microbiome and mental stress in cardiovascular disease
Acronym
A prospective observational study to examine the role of microbiome and mental stress in cardiovascular disease (STRESS-CVD study)
Scientific Title
Understanding development and repair of cardiovascular disease mediated by microbiome and mental stress
Scientific Title:Acronym
Understanding development and repair of cardiovascular disease mediated by microbiome and mental stress
Region
| Japan |
Condition
Condition
Aortic aneurysm
Stress-related cardiovascular disease: spontaneous coronary artery dissection(SCAD), takotsubo cardiomyopathy, acute heart failure, acute coronary syndrome, ischemic non occlusive coronary artery disease (INOCA), coronary vasospastic angina
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct microbiome analysis and mental stress assessment in patients with aortic diseases and stress-related cardiovascular diseases.
Furthermore, to elucidate the pathogenesis of cardiovascular diseases caused by specific symbiotic microbiome and mental stress, we will analyze inflammatory cytokines and metabolites mediated using blood samples, and evaluate and analyze pathological evaluation, microbiome analysis in tissue, and inflammatory cell infiltration using aneurysm surgery samples.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aortic aneurysm
Morphology of aortic aneurysm [The maximum aortic aneurysm diameter, expansion rate, Shaggy aorta scoring (Eur J Vasc Endovasc Surg. 2020 Jul;60(1):57-66.)] and and its association with the following matters.
1. Microbiome in the oral, intestinal, aneurysm
2. Blood bacterial metabolites, inflammatory markers, and stress markers
Stress-related cardiovascular disease
The occurrence of the composite endpoint(total death+ left ventricular thrombosis+ pericardial effusion+ left ventricular outflow tract obstruction+ acute decompensated heart failure+ fetal arrythemias) in hospital and its association with the following matters
1. Oral and intestinal microbiome
2. Blood bacterial metabolites, inflammatory markers, and stress markers
3. Stress status before and after onset of disease
4. Hormone levels in hair
Key secondary outcomes
Aortic aneurysm
The length of hospital and ICU stay, and the occurrence of the composite endpoint(total death+ reoperation+ rehospitalization+ cerebral infarction+ myocardial infarction+ acute decompensated heart failure+ arterial embolism+ ileus+ hepatic dysfunction+ renal dysfunction+ abnormal pericardial effusion+ worsening aortic regurgitation) up to one and three year post operation and its association with the following matters.
1. Microbiome in the oral, intestinal, and aneurysm
2. Blood bacterial metabolites, inflammatory markers, and stress markers
Stress-related cardiovascular disease
The length of hospital and ICU stay, and The Inter TAK Diagnostic score(Chadri JR, et al. Eur Heart J 2018; 39:2032-2046), and the score of nativeT1/ECV and the appearance of LGE, and the change in left ventricular ejection fraction on MRI and its association with the following matters
1. Oral and intestinal microbiome
2. Blood bacterial metabolites, inflammatory markers, and stress markers
3. Stress status before and after onset of disease
4. Hormone levels in hair
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 18 years of age or older at the time consent is obtained
2. Patients whose consent to participate in this study has been obtained by the patient or a surrogate
3. Patients hospitalized for artificial vessel replacement or stent graft insertion for aortic aneurysm
4. Patients hospitalized for stress-related cardiovascular diseases
Key exclusion criteria
1. patients who are judged by the investigator to be inappropriate to participate in this study
2. patients with irritable bowel syndrome or diseases that may cause changes in the intestinal microbiota, such as colostomy
3. patients who have received long-term antibiotic therapy within 4 weeks of obtaining consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Noguchi |
| Middle name | |
| Last name | Teruo |
Organization
National cerebral and cardiovascular center
Division name
Cardiovascular medicine department
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
TEL
0570-012-545
tnoguchi@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Hayakawa |
| Middle name | |
| Last name | Koji |
Organization
National cerebral and cardiovascular center
Division name
Cardiovascular department
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
TEL
0570-012-545
Homepage URL
http://www.ncvc.go.jp
hayakawa.koji@ncvc.go.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
AMED CREST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cerebral and cardiovascular center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
Tel
0570-012-545
hayakawa.koji@ncvc.go.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
| 2026 | Year | 10 | Month | 31 | 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
| 2024 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cases are currently being accumulated.
Management information
Registered date
| 2024 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063146
