UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019863 |
|---|---|
| Receipt number | R000022935 |
| Scientific Title | Prospective study for evaluating coronary microvascular dysfunction in patients with vasospastic angina |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2021/02/07 15:45:55 |
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Basic information
Public title
Prospective study for evaluating coronary microvascular dysfunction in patients with vasospastic angina
Acronym
Prospective study for evaluating coronary microvascular dysfunction in patients with vasospastic angina
Scientific Title
Prospective study for evaluating coronary microvascular dysfunction in patients with vasospastic angina
Scientific Title:Acronym
Prospective study for evaluating coronary microvascular dysfunction in patients with vasospastic angina
Region
| Japan |
Condition
Condition
vasospastic angina
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluating microvascular dysfunction in patients with vasospastic angina
Basic objectives2
Others
Basic objectives -Others
physiological assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the index of microcirculatory resistance (IMR) between patients with positive acetylcholine (ACh) provocation test and those with negative
Key secondary outcomes
1) Coronary flow reserve (CFR) in patients with positive or negative ACh provocation test
2) Relation between chest symptom and IMR or CFR
3) Relation between IMR or CFR and chest symptom in patients with negative ACh provocation test
4) IMR, CFR and mean transit time (MTT) which indicate coronary epicardial or microvascular spasm
5) Relation between reactive hyperemia index (RHI) and IMR, CFR, MTT, or positivity of ACh provocation test
6) Relation between RHI and chest symptom
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluation for coronary microvascular dysfunction with Certus Pressure Wire during ACh provocation test
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 planned to undergo ACh provocation test
2) Patients who discontinue coronary dilator >48 hours before ACh provocation test
Key exclusion criteria
1) Patients with hemodialysis
2) Patients with severe hepatic disorder
3) Patients with severe heart failure (ejection fraction <30% or NYHA >class 3)
4) Patients with prior coronary intervention for left anterior descending artery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
tsuchiya-chiba@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Saito |
Organization
Chiba University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
policemaccho@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2015 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
https://journals.lww.com/coronary-artery/Abstract/2019/06000/Decreased_resting_coronary_flow_and_imp
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/coronary-artery/Abstract/2019/06000/Decreased_resting_coronary_flow_and_imp
Number of participants that the trial has enrolled
40
Results
Patients with VSA had a significantly lower reactive hyperemia index compared with those without VSA. Coronary flow reserve, index of microcirculatory resistance, and hyperemic Tmn were not different between the two groups, whereas resting Tmn was significantly longer in patients with VSA. Although the frequency and severity of angina improved from baseline to 1 and 3 months in patients with both positive and negative ACh tests, there was no difference between the two groups.
Results date posted
| 2019 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Non-obstructive coronary artery disease
Participant flow
Patients who scheduled to undergo acetylcholine provocation test were included. Coronary circulation was evaluated invasively using a thermodilution method by obtaining the mean transit time at rest and hyperemia, coronary flow reserve, and index of microcirculatory resistance. Systemic endothelial function was assessed by the reactive hyperemia index.
Adverse events
Procedurerelated complications such as death, coronary dissection, wire-induced coronary vasospasm, arrhythmia, and cardiogenic
shock were recorded.
Outcome measures
index of microcirculatory resistance
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022935
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