Coronary Disease
Conditions
Keywords
Diagnostic Techniques, Cardiovascular, Coronary Angiography, Fractional Flow Reserve, Myocardial, Echocardiography, Stress
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.
Interventions
DIAGNOSTIC_TESTCT-FFR
Invasive FFR and CCTA With CT-FFR
DIAGNOSTIC_TESTStress echocardiography
Stress echocardiography and invasive FFR
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CT- FFR values by New Method as a dichotomous variable | 4 weeks | Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve |
| Worsening regional wall motion abnormality | 4 weeks | Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques |
Countries
Norway
Outcome results
None listed