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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015906

Enrollment

413

Registered

2014-12-10

Start date

2014-12-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable coronary disease with a single major coronary artery lesion

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patient who is adaptable to coronary angiography (CAG) or coronary revascularization (PCI/CABG) 2) Patient who has stable coronary artery disease with more than 50% diameter stenosis in a single major coronary artery on CAG by visual estimation 3) Age>=20 years old at time of getting informed consent 4) Patient who can understand and voluntarily sign the informed consent form

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactTakayama Hiroki

The study secretariat of DIASTOLE Study Soiken Inc.

takayama@soiken.com03-3295-1350

Outcome results