Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Disease

Intervention / Treatment
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* Diagnostic Test: CT-FFR
* Diagnostic Test: Stress echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%. Informed consent 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 BMI> 40 Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-FFR<br>Analyse With New CT-FFR Method | Diagnostic Test: CT-FFR<br>* Invasive FFR and CCTA With CT-FFR<br>|
| Active Comparator: Stress echocardiography<br>Analyse With invasive FFR and stress echocardiography | Diagnostic Test: Stress echocardiography<br>* Stress echocardiography and invasive FFR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT- FFR values by New Method as a dichotomous variable | Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve | 4 weeks | 
| Worsening regional wall motion abnormality | Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Techniques, Cardiovascular, Coronary Angiography, Fractional Flow Reserve, Myocardial, Echocardiography, Stress