UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054155 |
|---|---|
| Receipt number | R000061839 |
| Scientific Title | Diagnostic potential of relative changes in high-sensitivity troponin levels during intracoronary acetylcholine provocation testing |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/04/15 15:10:48 |
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Basic information
Public title
Diagnostic potential of relative changes in high-sensitivity troponin levels during intracoronary acetylcholine provocation testing
Acronym
Diagnostic potential of relative changes in high-sensitivity troponin levels during intracoronary acetylcholine provocation testing
Scientific Title
Diagnostic potential of relative changes in high-sensitivity troponin levels during intracoronary acetylcholine provocation testing
Scientific Title:Acronym
Diagnostic potential of relative changes in high-sensitivity troponin levels during intracoronary acetylcholine provocation testing
Region
| Japan |
Condition
Condition
Vasospastic angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Angina pectoris is a highly prevalent disease worldwide, which causes anginal chest symptoms due to myocardial ischemia by coronary artery stenosis and occlusion. Vasospastic angina (VSA), a subtype of angina pectoris, is based on the transient coronary vasoconstriction. Because VSA can be effectively managed by medical treatment, the accurate diagnosis of VSA is clinically important. When VSA is suspected but non-invasive testing is inconclusive, invasive diagnostic tests, including intracoronary acetylcholine (ACh) provocation, are recommended. The positive or negative ACh provocation testing was defined based on the angiographic vasospasm, electrocardiographic changes, and chest symptoms during the test. In real-world clinical practice, however, the diagnosis during ACh provocation testing is often challenging because of inconclusive angiographic vasospasm and atypical electrocardiographic changes and chest symptoms. Therefore, we designed the present study to evaluate the diagnostic potential of high sensitivity troponin as an objective marker for the diagnosis of VSA during ACh provocation testing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the diagnosis of vasospastic angina and levels of high sensitivity troponin I.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who are planned to undergo invasive coronary angiography with or without intracoronary acetylcholine provocation testing for the diagnosis of vasospastic angina at Chiba University Hospital.
Key exclusion criteria
1) Acute coronary syndrome
2) Cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, amyloidosis, Fabry disease, sarcoidosis, etc.)
3) Hemodialysis
4) No consent
5) Not appropriate for the study inclusion assessed by the study investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Cardiovascular Medicine
Zip code
2608677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
+81432227171
saitoyuichi1984@gamil.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Saito |
Organization
Chiba University Hospital
Division name
Cardiovascular Medicine
Zip code
2608677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
+81432227171
Homepage URL
saitoyuichi1984@gamil.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Observational Studies of Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
Tel
+81432227171
hsp-kansaturinri@chiba-u.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
| 2024 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In clinical practice, high sensitivity troponin I (hs-TnI) is used for the diagnosis and risk stratification in patients with acute coronary syndrome (ACS). In patients with suspected ACS but without elevated hs-TnI levels, the presence of myocardial ischemia and the possibility of ACS are strongly suspected when remesured hs-TnI levels are elevated at intervals of 30 minutes to 2 hours. Measuring hs-TnI levels before and after ACh provocation tests may provide an objective and noninvasive assessment of myocardial ischemia related to coronary spasms. In this study, we will assess whether the elevation of hs-TnI levels is associated with coronary spasms during ACh provocation tests.
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061839
