UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019309 |
|---|---|
| Receipt number | 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 11:33:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tnishi@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022304
