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Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR

Completed
Conditions
Coronary Artery Disease
Interventions
Device: CT-FFR. CTA. FFR
Registration Number
NCT03055780
Lead Sponsor
Toshiba Medical Systems Corporation, Japan
Brief Summary

The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.

Detailed Description

CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
59
Inclusion Criteria
  • suspected coronary artery disease
  • hemodynamically stable condition
Exclusion Criteria
  • hemodynamic instability
  • atrial fibrillation
  • morbid obesity (BMI≥40 kg/m2)
  • previous stent implantation
  • recent myocardial infarction (within 30 days)
  • age <40 years
  • renal insufficiency (eGFR <60mL/min/1.73m2)
  • bronchospastic lung disease requiring long term steroid therapy

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
CT-FFR. CTA. FFRCT-FFR. CTA. FFR59 patients with suspected CAD that have been scheduled for an interventional FFR study
Primary Outcome Measures
NameTimeMethod
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosisone day
Secondary Outcome Measures
NameTimeMethod
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