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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019309
Receipt No. R000022304
Scientific Title Hyperemic Efficacy of nicorandil for fractional flow reserve measurement in patients with stable coronary artery disease
Date of disclosure of the study information 2015/10/15
Last modified on 2016/12/26

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Basic information
Public title Hyperemic Efficacy of nicorandil for fractional flow reserve measurement in patients with stable coronary artery disease
Acronym Hyperemic efficacy of nicorandil
Scientific Title Hyperemic Efficacy of nicorandil for fractional flow reserve measurement in patients with stable coronary artery disease
Scientific Title:Acronym Hyperemic efficacy of nicorandil
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This randomized, prospective, crossover study is designed to investigate the hyperemic effect of intravenous nicorandil for fractional flow reserve (FFR) measurement compared with intravenous adenosine in the same patients with consecutive randomized patient-blinded infusions of intravenous adenosine and intravenous nicorandil.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FFR value
Key secondary outcomes The time to hyperemia; the plateau time; fluctuation; the number of functionally significant stenoses (FFR<0.75, FFR less than or equal to 0.80); hemodynamic parameters, ECG change and symptoms during FFR measurement.


Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Maneuver
Interventions/Control_1 Fractional flow reserve measurement with adenosine followed by nicorandil
Interventions/Control_2 Fractional flow reserve measurement with nicorandil followed by adenosine
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients with an angiographically intermediate lesion in a major epicardial coronary artery.
Age between 20 and 89 years and signed informed consent.
Key exclusion criteria Acute coronary syndrome within the previous 1 week,vessels with prior myocardial infarction, allergy to adenosine of nicorandil,asthma or chronic obstructive pulmonary disease on medical treatment, second or third degree atrioventricular block, severe valvular heart disease, acute decompensated heart failure, reduced left ventricular function (ejection fraction less than or equal to 30%), severe liver dysfunction, severe renal insufficiency, angle-closure glaucoma, patients who are taking phosphodiesterase type 5 (PDE5) Inhibitors, pregnancy, patients who were not suitable for enrollment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kobayashi
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2340
Email y@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nishi
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2340
Homepage URL
Email tnishi@chiba-u.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Chiba University Graduate School of Medicine
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 10 Month 15 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 Completed
Date of protocol fixation
2015 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 10 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022304

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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