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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040342
Receipt No. R000046035
Scientific Title Observational study for clinical importance of fractional flow reserve in patients with organic coronary stenosis and vasospastic angina
Date of disclosure of the study information 2020/05/08
Last modified on 2020/05/08

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Basic information
Public title Observational study for clinical importance of fractional flow reserve in patients with organic coronary stenosis and vasospastic angina
Acronym VSA-FFR Study
Scientific Title Observational study for clinical importance of fractional flow reserve in patients with organic coronary stenosis and vasospastic angina
Scientific Title:Acronym VSA-FFR Study
Region
Japan

Condition
Condition Angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the clinical importance and prognostic impact of fractional flow reserve in patients with VSA and organic coronary stenosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, urgent percutaneous coronary intervention, and hospitalization due to unstable angina pectoris during the follow-up periods.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ACh provocation testing for coronary artery spasm
Key exclusion criteria Proven cardiomyopathy
End-stage renal disease on hemodialysis
In-stent re-stenotic lesions in a major coronary artery
History of PCI within 3 months
Incomplete ACh provocation testing or measurement of FFR
Lost to follow-up
Target sample size 299

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Takahashi
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL +81227177152
Email jtakahashi@cardio.med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kiyotaka
Middle name
Last name Hao
Organization Tohoku University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL +81227177153
Homepage URL
Email hao@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science, and Technology, Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku university graduate school of medicine
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
Tel 022-728-4105
Email rinri-2@proj.med.tohoku.ac.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
2020 Year 05 Month 08 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 236
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 No longer recruiting
Date of protocol fixation
2018 Year 12 Month 23 Day
Date of IRB
2019 Year 01 Month 28 Day
Anticipated trial start date
2019 Year 01 Month 31 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively enrolled patients with suspected vasospastic angina who underwent acetylcholine provocation test for coronary spasm, and evaluated the incidence of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, urgent percutaneous coronary intervention, and hospitalization due to unstable angina pectoris during the median follow-up period of 656 days.

Management information
Registered date
2020 Year 05 Month 08 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046035

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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