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

St. Olavs Hospital

Status: Completed

Conditions: Coronary Disease

Treatments: Diagnostic Test: CT-FFR; Diagnostic Test: Stress echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03045601

2016/1609

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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182 participants in 2 patient groups

CT-FFR

Experimental group

Description:

Analyse With New CT-FFR Method

Treatment:

Diagnostic Test: CT-FFR

Stress echocardiography

Active Comparator group

Description:

Analyse With invasive FFR and stress echocardiography

Treatment:

Diagnostic Test: Stress echocardiography