Danish study of Non-Invasive testing in Coronary Artery Disease 2 (Dan-NICAD 2): Study design for a controlled study of diagnostic accuracy.

Adult Computed Tomography Angiography / methods Coronary Angiography / methods Coronary Artery Disease / diagnosis Cross-Sectional Studies Denmark Female Follow-Up Studies Fractional Flow Reserve, Myocardial / physiology Humans Magnetic Resonance Imaging, Cine / methods Male Multidetector Computed Tomography / methods Positron-Emission Tomography / methods Prospective Studies Reproducibility of Results

Journal

American heart journal

ISSN: 1097-6744

Titre abrégé: Am Heart J

Pays: United States

ID NLM: 0370465

Informations de publication

Date de publication:
09 2019

Historique:

received: 07 09 2018

accepted: 27 03 2019

pubmed: 20 7 2019

medline: 7 3 2020

entrez: 20 7 2019

Statut: ppublish

Résumé

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), 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 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.

Sections du résumé

BACKGROUND

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

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.

Identifiants

DOI: 10.1016/j.ahj.2019.03.016 PMID: 31323454

pubmed: 31323454

pii: S0002-8703(19)30083-3

doi: 10.1016/j.ahj.2019.03.016

pii:

doi:

Banques de données

ClinicalTrials.gov

['NCT03481712']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

114-128