UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040720 |
|---|---|
| Receipt number | R000046484 |
| Scientific Title | Assessment of the 10-year risk of coronary heart disease using the Suita score in stroke patients and association with stroke recurrence |
| Date of disclosure of the study information | 2020/06/11 |
| Last modified on | 2025/06/16 10:05:02 |
* 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
An observational study that assesses the risk of developing coronary heart disease in stroke patients and investigates the prognosis.
Acronym
Risk assessment of developing coronary heart disease in stroke patients and prognosis
Scientific Title
Assessment of the 10-year risk of coronary heart disease using the Suita score in stroke patients and association with stroke recurrence
Scientific Title:Acronym
Assessment of the 10-year risk of coronary heart disease in stroke patients and association with stroke recurrence
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of 10-years risk of developing coronary heart disease in stroke patients using the Suita score. Observation of the association between risk of developing coronary heart disease and recurrence of stroke.
Basic objectives2
Others
Basic objectives -Others
Association of risk of developing coronary heart disease in patients with stroke and stroke recurrence
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment risk of developing coronary heart disease in patients with ischemic stroke
Key secondary outcomes
Association of risk of developing coronary heart disease in patients with stroke and stroke recurrence
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 diagnosed and hospitalized for stroke
Key exclusion criteria
None
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Miyamoto |
| Middle name | |
| Last name | Yoshinori |
Organization
Brain Attack Center Ota Memorial Hospital
Division name
Division of Cardiology
Zip code
720-0825
Address
3-6-28 Okinogami, Fukuyama City, Hiroshima prefecture, Japan
TEL
0849318650
miyamox0707@gmail.com
Public contact
Name of contact person
| 1st name | Miyamoto |
| Middle name | |
| Last name | Yoshinori |
Organization
Brain Attack Center Ota Memorial Hospital
Division name
Division of Cardiology
Zip code
720-0825
Address
3-6-28 Okinogami, Fukuyama City, Hiroshima prefecture, Japan
TEL
0849318650
Homepage URL
miyamox0707@gmail.com
Sponsor or person
Institute
Division of Cardiology, Brain Attack Center Ota Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Brain Attack Center Ota Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Department of Ota cerebrovascular research institution
Address
3-6-28 Okinogami, Fukuyama City, Hiroshima prefecture, Japan
Tel
0849318650
fukusima@shouwa.or.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
脳神経センター大田記念病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/internalmedicine/61/6/61_7905-21/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/61/6/61_7905-21/_article
Number of participants that the trial has enrolled
1204
Results
Of 1,204 patients, 937 (78%) were classified as high CHD risk. Stroke recurrence occurred in 66 patients during follow-up. Multivariate analysis showed that, after adjusting for factors such as non-small vessel occlusion and lipid-lowering therapy at discharge, a >=5% predicted CHD risk was significantly associated with 1-year stroke recurrence.
Results date posted
| 2025 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 1,372 patients with first-ever AIS or TIA were admitted to our hospital between April 13, 2016, and June 30, 2018. We evaluated the Suita score for 1,333 of the patients admitted during the study period, excluding those for whom the Suita score was not evaluated during admission, those who died (mRS 6) before discharge (n = 30), those who died within 3 months after discharge (n = 41), and those who underwent carotid endarterectomy (n = 58) within 1 year from the AIS or TIA onset. Ultimately, 1,204 patients were included in the final analyses. According to the Suita score, a total of 937 (78%) patients were classified as being at high risk (risk of developing CHD >= 5%). The median (IQR) age was 75 (66-83) years old, 56% of the patients were men, and the median baseline NIHSS score was 3 points. Furthermore, 46% of the patients were prescribed or administered oral lipid-lowering agents at the time of discharge. Compared to the low-risk group, patients in the high-risk group were more likely to be older, men, obese, current smokers and drinkers, and diagnosed with hypertension, DM, dyslipidemia, and CKD. However, the age, sex, hypertension, DM, dyslipidemia, and CKD were factors associated with the Suita score. On dividing ischemic stroke into subtypes, large-artery atherosclerosis was the most prevalent subtype in the high-risk group. The rates of AF, CHD, and heart failure as well as the median NIHSS score at the time of admission, median LOS, mRS score at discharge, and prescription rate of antithrombotic agents at discharge did not differ markedly between the groups.
Participant flow
The Suita score was calculated at the time of hospitalization. Patients were categorized into 9 groups based on the predicted risk of developing CHD within the next 10 years, as follows: <1%, 1%, 2%, 3%, 5%, 9%, 14%, 22%, and >=28%.
Adverse events
No adverse events for prospective cohort study
Outcome measures
In our hospital, patients admitted due to stroke are usually followed up regularly after discharge (once a year), and their outcomes are measured annually, even if they are being treated at another hospital. In the current study, the primary outcome was stroke recurrence within one year from the initial onset. Recurrent stroke was defined as ischemic stroke, cerebral hemorrhaging, or TIA. Cerebral hemorrhaging was defined as acute extravasation of blood into the brain parenchyma based on neuroimaging data. According to neuroimaging data, TIA was defined as the development of new neurological symptoms or deficits lasting <24 h with no evidence of new infarction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Assessment of risk of coronary artery disease in patients with stroke and its association with stroke recurrence
Assessment of risk of atherosclerotic cardiovascular disease risk in stroke patients
Identification of stroke recurrence predictors
Evaluation of lifestyle habits of stroke patients
Management information
Registered date
| 2020 | Year | 06 | Month | 11 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046484
