NPO Associations for Establishment of Evidence in Interventions
Minato, Tokyo, 105-0013, Japan
NCT Number: NCT02002910
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.
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Notify Me20 year and older
All sexes
Observational
Minato, Tokyo, 105-0013, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline pocedure
Alteration in treatment protocol. Change in SYNTAX score.
Time frame: 1year after the pocedure
MACCE include all-cause death, cerebrovascular accident(CVA), myocardial infarction(MI), and repeat revascularization.
Time frame: baseline pocedure
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).
Time frame: beseline procedure
Treatment categorization disagreements of iFR and FFR are analyzed by multi-variable analysis processing to calculate Characteristic factors.
Associations for Establishment of Evidence in Interventions
Other
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