UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016059 |
|---|---|
| Receipt number | R000018663 |
| Scientific Title | Exercise Stress Echocardiography Compared with Fractional Flow Reserve for the Detection of Significant Coronary Stenosis: Using Multilayer Strain |
| Date of disclosure of the study information | 2014/12/26 |
| Last modified on | 2016/12/26 11:32:21 |
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Basic information
Public title
Exercise Stress Echocardiography Compared with Fractional Flow Reserve for the Detection of Significant Coronary Stenosis: Using Multilayer Strain
Acronym
Exercise Stress Echocardiography Versus Fractional Flow Reserve
Scientific Title
Exercise Stress Echocardiography Compared with Fractional Flow Reserve for the Detection of Significant Coronary Stenosis: Using Multilayer Strain
Scientific Title:Acronym
Exercise Stress Echocardiography Versus Fractional Flow Reserve
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether the assessment of myocardial deformation using multilayer strain during exercise stress echocardiography is useful to detect functional significant coronary artery stenosis confirmed by invasive fractional flow reserve.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change of endocardial longitudinal strain at rest and after exercise in the myocardial territories supplied by coronary vessels with or without fractional flow reserve less than or eual to 0.80
Key secondary outcomes
Comparison of following parameters assessed by two dimensional or three dimensional speckle tracking echocardiography in the myocardial territories supplied by coronary vessels with or without fractional flow reserve < or = 0.80 (or < 0.75):
Endocardial, epicardial, all-layer longitudinal strain,
Circumferential strain
Radial strain
Post systolic index
Time to peak strain
Time to peak strain index
Time from AVC to peak strain
Comparison of global longitudinal strain with BNP
ECG changes during ecercise echocardiography
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
| Maneuver |
Interventions/Control_1
Exercise echocardiography and fractional flow reserve measurement
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
1. Patients who will undergo a coronary angiography or a percutaneous coronary intervention with coronary artery disease, defined as greater than or equal to 50% diameter stenosis by visual estimation, in one or more major epicardial coronary arteries
2. Twenty years of age and older
3. Able to provide informed, written consent
Key exclusion criteria
1. Patients with lesions localized on right coronary ostia or left main coronary artery
2. Atrial fibrillation
3. Recent myocardial infarction (within 7 days)
4. Severe valvular heart disease
5. Decompensated heart failure
6. Advanced renal failure (estimated glomerular filtration rate less than or equal to 30 ml/min)
7. Severe left ventricular dysfunction (ejection fraction less than or equal to 30%)
8. Patients who cannot peddle an ergometer for any reason
9. Pregnant
10. Contraindication to both adenosine triphosphate and papaverine.
11. Patients judged as inappropriate for trial entry
Target sample size
30
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 city, Chiba, Japan
TEL
043-226-2340
aapa6508@chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nishi |
Organization
Chiba university hospital
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
| 2014 | Year | 12 | Month | 26 | 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
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 26 | 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=R000018663
