UMIN-CTR Clinical Trial

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
Email	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
Email	policemaccho@yahoo.co.jp

Sponsor
Institute	Chiba University Hospital, Department of Cardiovascular Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022935