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Clinical Trials/NCT03045601
NCT03045601
Completed
Not Applicable

Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve

St. Olavs Hospital1 site in 1 country182 target enrollmentFebruary 21, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
St. Olavs Hospital
Enrollment
182
Locations
1
Primary Endpoint
Worsening regional wall motion abnormality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.

Registry
clinicaltrials.gov
Start Date
February 21, 2017
End Date
March 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patients with unstable coronary artery disease.
  • Previously treated with PCI or coronary surgery.
  • Severe renal impairment i.e. GFR \<30ml / min
  • Contrast allergy
  • Contraindication to adenosine / nitroglycerin / beta-blocker
  • Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar

Outcomes

Primary Outcomes

Worsening regional wall motion abnormality

Time Frame: 4 weeks

Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques

CT- FFR values by New Method as a dichotomous variable

Time Frame: 4 weeks

Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve

Study Sites (1)

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