Diagnostic accuracy of diastolic fractional flow reserve (d-FFR) for functional evaluation of coronary stenosis

Not Applicable

• Conditions: Stable coronary disease with a single major coronary artery lesion

• Registration Number: JPRN-UMIN000015906
• Lead Sponsor: PO Association for Thinking about the Future of the Heart Angioplasty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-10
• Study Completion: 2020-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patient who has left main trunk lesion 2) Chronic total occlusion (CTO) lesion 3) lesion that is in-stent restenosis 4) Patient who has multivessel coronary artery disease 5) Patient who is diagnosed with ST-segment elevation acute myocardial infarction 6) Culprit lesion of non ST-segment elevation acute coronary syndrome 7) Patient who has anamnesis of old myocardial infarction 8) Patient who meets a contraindication of ATP (Adenosine triphosphate disodium hydrate) 9) Patient with frequent ventricular extrasystole, and with atrial/auricular flutter or fibrillation 10) Patient who is diagnosed left heart failure or altitude valvular disease 11) Patient with a history of coronary artery bypass graft (CABG) 12) Patient with severe renal dysfunction (eGFR < 30mL/min/1.73m2) 13) Patient who doesn't agree to provide the informed consent 14) Patient is concluded unsuitable by a docter in charge of the present clinical research

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference of the accuracy rate from the d-FFR and full cardiac cycle FFR using myocardial scintigraphy as a golden standard

Secondary Outcome Measures

Name	Time	Method
1) The cutoff value of d-FFR and FFR using myocardial scintigraphy as a golden standard 2) Assess the sensitivity and the specificity, the positive-predictive value, the negative-predictive value of diastolic Pd/Pa at rest and Pd/Pa at rest using myocardial scintigraphy as a golden standard 3) The cutoff value of diastolic Pd/Pa at rest and Pd/Pa at rest using myocardial scintigraphy as a golden standard 4) Assess the sensitivity and the specificity, the positive-predictive value, the negative-predictive value of myocardial scintigraphy using FFR as a golden standard 5) Assess the sensitivity and the specificity, the positive-predictive value, the negative-predictive value of myocardial scintigraphy using d-FFR as a golden standard