Coronary Artery DiseaseNCT02002910
Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect
An observational study of Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.
Trial summary
To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 421 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who is adaptable to CAG and/or coronary revascularization
Who may be able to join
- Age>=20 years old.
- Patient who can understand informed consent of the clinical study and signed the consent.
- Patient who is adaptable to CAG and/or coronary revascularization
- Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.
Who cannot join
- Patient with known contraindications to Adenosine Triphosphate(ATP) and/or papaverine hydrochloride
- Target vessel diameter<=2.0mm
- Lesion with Chronic Total Occlusion(CTO) (registration allowed if other branch has stenosis more than 50% in visual judgment)
- Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block.
- Acute Myocardial Infarction(AMI) patient
- Patient who is disqualified for FFR and coronary revascularization by the investigator.
Show all 23Show fewer
- Lesion is disqualified for Percutaneous Coronary Intervention(PCI) by the investigator.
- Patient who has critical valvular disease of heart. (moderate or severe Aortic valve stenosis(AS)/Aortic Regurgitation(AR)/Mitral Stenosis(MS)/Mitral Regurgitation(MR)）
- Patient with a prior Coronary Artery Bypass Graft(CABG) on target vessel.
- Patient with severe renal dysfunction. (serum creatinine>=2.0mg/dl)
- Patient on hemodialysis.
- Body weight>=200kg
- Patient who needs ventricular assist device to ensure hemodynamic stability (heart rate<50/min, SBP<90mmHg)
- Patient who expects to live less than 2 years at the registration
- Patient with contraindications to an antithrombotic therapy or an anticoagulant therapy.
- Patient who is poor compliance with drug treatment.
- Patient who is allergic to contrast agent.
- Left Ventricular Ejection Fraction(LVEF)>=30%
- Patient who has the history of PCI with Drug-Eluting Stent(DES) in recent 3 months before registration.
- Patient who has the history of PCI with Bare Metal Stent(BMS) or Plain Old Balloon Atherectomy(POBA) in recent 1 year before registration.
- Patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the PCI.
- Patients with inadequacy to join this clinical study.
- Patient who has been enrolled any other clinical study.
Trial locations and contacts
1 site in 1 country.
Japan1 site
NPO Associations for Establishment of Evidence in Interventions
Minato, Tokyo, 105-0013
About this study
To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis.
To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.
- Conditions
- Coronary Artery Disease
- Keywords
- iFR, FFR, Medical Economy, physiological assessment, SYNTAX score
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical economy
To evaluate the healthcare cost-effectiveness in QALY（Quality Adjusted Life Year）converted by Japanese functional score ; Quality of Life(QOL) questionnaire (EQ-5D) and the cost postulated by CAG strategy with its iFR/FFR hybrid strategy.
To collect the healthcare cost related MACCE at the timing of 6 and 12 months FU point. (Included emergency visit) To collect QOL questionnaire (EQ-5D) at the timing of just after the treatment and 12 months follow up point.
Measured: 1 year after the procedure
Physiological assessment
Alteration in treatment protocol. Change in SYNTAX score.
Measured: baseline pocedure
Secondary outcomes (3)
Incidence of major adverse cardiac and cerebrovascular events(MACCE)
MACCE include all-cause death, cerebrovascular accident(CVA), myocardial infarction(MI), and repeat revascularization.
Measured: 1year after the pocedure
correlated analysis
Area under receiver-operating characteristic curve(ROC) Classification agreement between iFR and FFR in this registry, Demonstrated using the area under the receiver-operating characteristic curve(FFR cut-off 0.8 or 0.75).
Measured: baseline pocedure
evaluation of variance
Treatment categorization disagreements of iFR and FFR are analyzed by multi-variable analysis processing to calculate Characteristic factors.
Measured: beseline procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associations for Establishment of Evidence in Interventions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masato Nakamura, M.D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002910
- Sponsor's protocol ID
- J-DEFINE
- Status last verified
- Jan 2017
- First submitted
- 28 Oct 2013
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japan Study of Distal Evaluation of Functional Significance of Intra-arterial Stenosis Narrowing Effect
- ClinicalTrials.gov ID
- NCT02002910
- Acronym / sponsor ID
- J-DEFINE
- Conditions
- Coronary Artery Disease
- Keywords
- iFR, FFR, Medical Economy, physiological assessment, SYNTAX score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Associations for Establishment of Evidence in InterventionsUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis.
To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who is adaptable to CAG and/or coronary revascularization
Key inclusion criteria (4 listed)
- Age>=20 years old.
- Patient who can understand informed consent of the clinical study and signed the consent.
- Patient who is adaptable to CAG and/or coronary revascularization
- Patient who has evaluated stenotic lesion (stenosis>50% in visual judgment) by CAG at main epicardial vessel and its branch or who suspected to have it.
Key exclusion criteria (23 listed)
- Patient with known contraindications to Adenosine Triphosphate(ATP) and/or papaverine hydrochloride
- Target vessel diameter<=2.0mm
- Lesion with Chronic Total Occlusion(CTO) (registration allowed if other branch has stenosis more than 50% in visual judgment)
- Patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block.
- Acute Myocardial Infarction(AMI) patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medical economy
Time frame: 1 year after the procedure
To evaluate the healthcare cost-effectiveness in QALY（Quality Adjusted Life Year）converted by Japanese functional score ; Quality of Life(QOL) questionnaire (EQ-5D) and the cost postulated by CAG strategy with its iFR/FFR hybrid strategy. To collect the healthcare cost related MACCE at the timing of 6 and 12 months FU point. (Included emergency visit) To collect QOL questionnaire (EQ-5D) at the timing of just after the treatment and 12 months follow up point.
Physiological assessment
Time frame: baseline pocedure
Alteration in treatment protocol. Change in SYNTAX score.
3 secondary outcomes
Incidence of major adverse cardiac and cerebrovascular events(MACCE)
Time frame: 1year after the pocedure
correlated analysis
Time frame: baseline pocedure
evaluation of variance
Time frame: beseline procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masato Nakamura, M.D study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical economy (time frame: 1 year after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.