Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2):Study design for a controlled study of diagnostic accuracy
| Autor: | Simon Winther, L Brix, Steffen E. Petersen, Grazina Urbonaviciene, Hans Erik Bøtker, Osama Hammid, Evald Høj Christiansen, Ashkan Eftekhari, Niels Ramsing Holm, Laust Dupont Rasmussen, Amedeo Chiribiri, Morten Bøttcher, Lars Knudsen, Jane Kirk, Hanne Maare Søndergaard, Lars Frost, Mette Nyegaard, Lars C. Gormsen, June Anita Ejlersen, Jelmer Westra, Lene Helleskov Madsen, Samuel Emil Schmidt, Christin Isaksen |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Fractional Flow Reserve Myocardial/physiology Computed Tomography Angiography medicine.medical_treatment Denmark COMPUTED-TOMOGRAPHY ANGIOGRAPHY CAD Magnetic Resonance Imaging Cine/methods Fractional flow reserve Coronary Artery Disease 030204 cardiovascular system & hematology Coronary Angiography Coronary artery disease 0302 clinical medicine FRACTIONAL FLOW RESERVE 030212 general & internal medicine Prospective Studies Prospective cohort study Computed Tomography Angiography/methods MAGNETIC-RESONANCE PERFUSION medicine.diagnostic_test MYOCARDIAL BLOOD-FLOW Fractional Flow Reserve Myocardial Positron emission tomography HEART Female Radiology Cardiology and Cardiovascular Medicine Adult medicine.medical_specialty WAVE-FREE RATIO Magnetic Resonance Imaging Cine Revascularization STENOSIS 03 medical and health sciences Multidetector Computed Tomography/methods Cardiac magnetic resonance imaging Multidetector Computed Tomography medicine Humans cardiovascular diseases Coronary Angiography/methods business.industry Reproducibility of Results PERFORMANCE QUANTIFICATION medicine.disease Positron-Emission Tomography/methods Stenosis PET Cross-Sectional Studies Positron-Emission Tomography Coronary Artery Disease/diagnosis business Follow-Up Studies |
| Zdroj: | Rasmussen, L D, Winther, S, Westra, J, Isaksen, C, Ejlersen, J A, Brix, L, Kirk, J, Urbonaviciene, G, Søndergaard, H M, Hammid, O, Schmidt, S E, Knudsen, L L, Madsen, L H, Frost, L, Petersen, S E, Gormsen, L C, Christiansen, E H, Eftekhari, A, Holm, N R, Nyegaard, M, Chiribiri, A, Bøtker, H E & Böttcher, M 2019, ' Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2) : Study design for a controlled study of diagnostic accuracy ', American Heart Journal, vol. 215, pp. 114-128 . https://doi.org/10.1016/j.ahj.2019.03.016 Rasmussen, L D, Winther, S, Westra, J, Isaksen, C, Ejlersen, J A, Brix, L, Kirk, J, Urbonaviciene, G, Søndergaard, H M, Hammid, O, Schmidt, S E, Knudsen, L L, Madsen, L H, Frost, L, Petersen, S E, Gormsen, L C, Christiansen, E H, Eftekhari, A, Holm, N R, Nyegaard, M, Chiribiri, A, Bøtker, H E & Böttcher, M 2019, ' Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2) : study design for a controlled study of diagnostic accuracy ', American Heart Journal, vol. 215, pp. 114-128 . https://doi.org/10.1016/j.ahj.2019.03.016 |
| DOI: | 10.1016/j.ahj.2019.03.016 |
| Popis: | Background: Coronary computed tomography angiography (CTA) is the preferred primary diagnostic modality when examining patients with low to intermediate pre-test probability of coronary artery disease (CAD). Only 20-30% of these have potentially obstructive CAD. Because of the relatively poor positive predictive value of coronary CTA, unnecessary invasive coronary angiographies (ICAs) are conducted with the costs and risks associated with the procedure. Hence, an optimized diagnostic CAD algorithm may reduce the numbers of ICAs not followed by revascularization. The Dan-NICAD 2 study has 3 equivalent main aims: (1) To examine the diagnostic precision of a sound-based diagnostic algorithm, The CADScor®System (Acarix A/S, Denmark), in patients with a low to intermediate pre-test risk of CAD referred to a primary examination by coronary CTA. We hypothesize that the CADScor®System provides better stratification prior to coronary CTA than clinical risk stratification scores alone. (2) To compare the diagnostic accuracy of 3T cardiac magnetic resonance imaging (3T CMRI), 82rubidium positron emission tomography ( 82Rb-PET), and CT-derived fractional flow reserve (FFR CT) in patients where obstructive CAD cannot be ruled out by coronary CTA using ICA fractional flow reserve (FFR) as reference standard. (3) To compare the diagnostic performance of quantitative flow ratio (QFR) and ICA-FFR in patients with low to intermediate pre-test probability of CAD using 82Rb-PET as reference standard. Methods: Dan-NICAD 2 is a prospective, multicenter, cross-sectional study including approximately 2,000 patients with low to intermediate pre-test probability of CAD and without previous history of CAD. Patients are referred to coronary CTA because of symptoms suggestive of CAD, as evaluated by a cardiologist. Patient interviews, sound recordings, and blood samples are obtained in connection with the coronary CTA. If coronary CTA does not rule out obstructive CAD, patients will be examined by 3T CMRI 82Rb-PET, FFR CT, ICA, and FFR. Reference standard is ICA-FFR. Obstructive CAD is defined as an FFR ≤0.80 or as high-grade stenosis (>90% diameter stenosis) by visual assessment. Diagnostic performance will be evaluated as sensitivity, specificity, predictive values, likelihood ratios, calibration, and discrimination. Enrolment started January 2018 and is expected to be completed by June 2020. Patients are followed for 10 years after inclusion. Discussion: The results of the Dan-NICAD 2 study are expected to contribute to the improvement of diagnostic strategies for patients suspected of CAD in 3 different steps: risk stratification prior to coronary CTA, diagnostic strategy after coronary CTA, and invasive wireless QFR analysis as an alternative to ICA-FFR. |
| Databáze: | OpenAIRE |
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