UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020942 |
|---|---|
| Receipt number | R000024166 |
| Scientific Title | Study of HDL function in patients with vasospastic angina. |
| Date of disclosure of the study information | 2016/02/09 |
| Last modified on | 2025/08/15 16:43:43 |
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Basic information
Public title
Study of HDL function in patients with vasospastic angina.
Acronym
Vasospastic angina and HDL function
Scientific Title
Study of HDL function in patients with vasospastic angina.
Scientific Title:Acronym
Vasospastic angina and HDL function
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between HDL function and pathogenesis of vasospastic angina.
Basic objectives2
Others
Basic objectives -Others
To explore novel risk factors for the diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HDL function (the ability of cholesterol efflux, antioxidant effects, anti-inflammatory effects, endothelial function)
Key secondary outcomes
Blood analyses including Hemoglobin A1c levels, Lipid profile, renal function, hepatic function, etc.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been diagnosed as vasospastic angina with acetylcholine provocation test.
2) Patients who are planned to undergo acetylcholine provocation test due to suspicion of vasospastic angina
3)Patients who gave written informed consent
Key exclusion criteria
1) Patients who have residual organic coronary obstructive lesions which need revascularization
2) End-stage renal disease (eGFR<30 ml/min) except for patients under hemodialysis
3) Subjects who are pregnant or hope to be pregnant
4) Shock
5) Subjects whose doctor in charge do not agree to join the trial
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Sakurada |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL
04-2940-8611
ayaori@ba2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ezaki |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL
04-2940-8611
Homepage URL
hirotakaezaki@gmail.com
Sponsor or person
Institute
Tokorozawa Heart Center
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Tokorozawa Heart Center
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
Tel
04-2940-8611
cs.thc@oukai.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0009898125002177?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0009898125002177?via%3Dihub
Number of participants that the trial has enrolled
83
Results
The present study indicated that CUC was a novel indicator of vasospasm-related HDL dysfunctionality and S1P was a novel biomarker for treated patients with VSA. The cholesterol efflux pathway and sphingolipid metabolism would contribute to the etiology of vasospasm and be the best candidates for new VSA treatments.
Results date posted
| 2025 | Year | 08 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients with VSA diagnosed by the Ach provocation test.
The patients without VSA excluded by the Ach provocation test.
Participant flow
Among 83 patients
initially assessed for inclusion, 6 were excluded based on the following
criteria: coronary artery stenting (n =3), cancer (n =1), hemodialysis
(n =1), and hyperthyroidism (n =1). Consequently, 77 patients were
included in the final analysis. Fifty-three patients with suspected VAS
were admitted to Tokorozawa Heart Center. After fasting from the
previous night, the patients underwent the acetylcholine provocation
test and were assigned to groups according to the result as follows. We
defined patients who were positive in the acetylcholine provocation test
as VSA at diagnosis group (n =32) and those who were negative as Non-
VSA group (n-21). Additionally, we enrolled outpatients who had
already been diagnosed with VSA and were under treatment with calcium
channel blockers or nitrates. We defined these patients as VSA
outpatient group (n =24).
Adverse events
none
Outcome measures
cholesterol uptake capacity
PON-1 activity
S1P
ApoM
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 12 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 12 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 28 | Day |
Other
Other related information
Clinical observation trial.
Objective;
200 patients who have undergone acethylcholine provocation test and diagnosed as vasospastic angina , or who are planning to undergo acethylcholine provocation test due to suspicion of vasospastic angina. Patients who gave written informed consent.
Measurements;
HDL function (the ability of cholesterol efflux, antioxidant effects, anti-inflammatory effects, endothelial function)
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024166
