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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020942
Receipt No. 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 2020/08/12

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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
Email 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
Email hirotakaezaki@gmail.com

Sponsor
Institute Tokorozawa Heart Center
Institute
Department

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
Email 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
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
2016 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2020 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024166

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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