Danish study of Non-Invasive testing in Coronary Artery Disease Dan-NICAD: study protocol for a randomised controlled trialReport as inadecuate




Danish study of Non-Invasive testing in Coronary Artery Disease Dan-NICAD: study protocol for a randomised controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 17:262

First Online: 26 May 2016Received: 11 October 2015Accepted: 11 May 2016DOI: 10.1186-s13063-016-1388-z

Cite this article as: Nissen, L., Winther, S., Isaksen, C. et al. Trials 2016 17: 262. doi:10.1186-s13063-016-1388-z

Abstract

BackgroundCoronary computed tomography angiography CCTA is an established method for ruling out coronary artery disease CAD. Most patients referred for CCTA do not have CAD and only approximately 20–30 % of patients are subsequently referred to further testing by invasive coronary angiography ICA or non-invasive perfusion evaluation due to suspected obstructive CAD. In cases with severe calcifications, a discrepancy between CCTA and ICA often occurs, leading to the well-described, low-diagnostic specificity of CCTA. As ICA is cost consuming and involves a risk of complications, an optimized algorithm would be valuable and could decrease the number of ICAs that do not lead to revascularization.

The primary objective of the Dan-NICAD study is to determine the diagnostic accuracy of cardiac magnetic resonance imaging CMRI and myocardial perfusion scintigraphy MPS as secondary tests after a primary CCTA where CAD could not be ruled out. The secondary objective includes an evaluation of the diagnostic precision of an acoustic technology that analyses the sound of coronary blood flow. It may potentially provide better stratification prior to CCTA than clinical risk stratification scores alone.

Methods-designDan-NICAD is a multi-centre, randomised, cross-sectional trial, which will include approximately 2,000 patients without known CAD, who were referred to CCTA due to a history of symptoms suggestive of CAD and a low-risk to intermediate-risk profile, as evaluated by a cardiologist. Patient interview, sound recordings, and blood samples are obtained in connection with the CCTA. All patients with suspected obstructive CAD by CCTA are randomised to either stress CMRI or stress MPS, followed by ICA with fractional flow reserve FFR measurements. Obstructive CAD is defined as an FFR below 0.80 or as high-grade stenosis >90 % diameter stenosis by visual assessment.

Diagnostic performance is evaluated as sensitivity, specificity, predictive values, likelihood ratios, and C statistics. Enrolment commenced in September 2014 and is expected to be complete in May 2016.

DiscussionDan-NICAD is designed to assess whether a secondary perfusion examination after CCTA could safely reduce the number of ICAs where revascularization is not required. The results are expected to add knowledge about the optimal algorithm for diagnosing CAD.

Trial registrationClinicaltrials.gov identifier, NCT02264717. Registered on 26 September 2014.

KeywordsCoronary artery disease Coronary computed tomography angiography Myocardial perfusion scintigraphy Cardiac magnetic resonance imaging Coronary angiography Fractional flow reserve Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1388-z contains supplementary material, which is available to authorized users.

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Author: Louise Nissen - Simon Winther - Christin Isaksen - June Anita Ejlersen - Lau Brix - Grazina Urbonaviciene - Lars Frost - L

Source: https://link.springer.com/







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