UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exercise Stress Echocardiography Compared with Fractional Flow Reserve for the Detection of Significant Coronary Stenosis: Using Multilayer Strain
Title of the study (Brief title)	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	Yoshio Kobayashi
Organization	Chiba University Hospital
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-226-2340
Email	aapa6508@chiba-u.jp

Public contact
Name of contact person	Takeshi Nishi
Organization	Chiba university hospital
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018663