Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with symptoms suggestive of coronary artery disease: rationale and design of the prospective, randomised, controlled, parallel-group multicenter FILTER-SCAD trial.

Autor:	Bjerking LH; Department of Cardiology, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark louise.hougesen.bjerking@regionh.dk., Hansen KW; Department of Cardiology, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.; Department of Cardiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark., Biering-Sørensen T; Department of Cardiology, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.; Department of Cardiology, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark., Brønnum-Schou J; Department of Cardiology, Amager Hospital, University of Copenhagen, Copenhagen, Denmark., Engblom H; Department of Clinical Physiology, Skåne University Hospital Lund, Lund, Sweden., Erlinge D; Department of Clinical Science, Skåne University Hospital Lund, Lund, Sweden., Haahr-Pedersen SA; Department of Cardiology, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark., Heitmann M; Department of Cardiology, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark., Hove JD; Department of Cardiology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark.; Center of Functional Imaging and Research, Amager Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark., Jensen MT; Department of Cardiology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark., Kruse M; Danish Centre for Health Economics (DaCHE), Syddansk Universitet, Odense, Denmark., Räder S; Department of Cardiology, Nordsjællands Hospital, University of Copenhagen, Hillerød, Denmark., Strange S; The Danish Association of Practicing Medical Specialists, Copenhagen, Denmark., Galatius S; Department of Cardiology, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark., Prescott EIB; Department of Cardiology, Bispebjerg Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Aug 23; Vol. 11 (8), pp. e049380. Date of Electronic Publication: 2021 Aug 23.
DOI:	10.1136/bmjopen-2021-049380
Abstrakt:	Introduction: Most patients with symptoms suggestive of chronic coronary syndrome (CCS) have no obstructive coronary artery disease (CAD) and better selection of patients to be referred for diagnostic tests is needed. The CAD-score is a non-invasive acoustic measure that, when added to pretest probability of CAD, has shown good rule-out capabilities. We aimed to test whether implementation of CAD-score in clinical practice reduces the use of diagnostic tests without increasing major adverse cardiac events (MACE) rates in patients with suspected CCS. Methods and Analysis: FILTER-SCAD is a randomised, controlled, multicenter trial aiming to include 2000 subjects aged ≥30 years without known CAD referred for outpatient assessment for symptoms suggestive of CCS. Subjects are randomised 1:1 to either the control group: standard diagnostic examination (SDE) according to the current guidelines, or the intervention group: SDE plus a CAD-score. The subjects are followed for 12 months for the primary endpoint of cumulative number of diagnostic tests and a safety endpoint (MACE). Angina symptoms, quality of life and risk factor modification will be assessed with questionnaires at baseline, 3 months and 12 months after randomisation. The study is powered to detect superiority in terms of a reduction of ≥15% in the primary endpoint between the two groups with a power of 80%, and non-inferiority on the secondary endpoint with a power of 90%. The significance level is 0.05. The non-inferiority margin is set to 1.5%. Randomisation began on October 2019. Follow-up is planned to be completed by December 2022. Ethics and Dissemination: This study has been approved by the Danish Medical Agency (2019024326), Danish National Committee on Health Research Ethics (H-19012579) and Swedish Ethical Review Authority (Dnr 2019-04252). All patients participating in the study will sign an informed consent. All study results will be attempted to be published as soon as possible. Trial Registration Number: NCT04121949; Pre-results. Competing Interests: Competing interests: LHB, KWH, JB-S, HE, SAH-P, MH, JDH, MK, MTJ, SR, SS, SG and EP: None. TB-S: Steering Committee member of the Amgen financed GALACTIC-HF trial; Advisory Board: Sanofi Pasteur; Advisory Board: Amgen; Speaker Honorarium: Novartis; Speaker Honorarium: Sanofi Pasteur; Research grant: GE Healthcare; Research grant: Sanofi Pasteur. DE: Advisory board for Acarix A/S. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu