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Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial.

ABSTRACT: Current guidelines for the diagnosis and management of patients with stable coronary artery disease (CAD) recommend functional stress testing for risk stratification prior to revascularization procedures. Cardiac magnetic resonance imaging (CMR) is a modality of choice for stress testing because of its capability to detect myocardial ischemia sensitively and specifically. Nevertheless, evidence from randomized trials evaluating a CMR-based management of stable CAD patients in comparison to a more common angiography-based approach still is limited.Patients presenting themselves with symptoms indicating a stable CAD and a class I or IIa indication for diagnostic coronary angiography are prospectively screened and enrolled in the study. All subjects receive a basic cardiological work-up and guideline-directed medical therapy. A 1:1 randomization in two groups is being performed. Patients in group 1 undergo diagnostic coronary angiography and subsequent revascularization according to current guidelines. Subjects in group 2 undergo adenosine stress CMR and in case of myocardial ischemia are sent to coronary angiography. Follow-up is planned for 3 years. During this time, the number of primary endpoints (defined as cardiac death and non-fatal myocardial infarction) and unplanned invasive procedures will be documented. Furthermore, symptom burden and quality of life will be assessed by use of the Seattle Angina Questionnaire. Sample size is calculated to prove non-inferiority of the CMR-based approach.In case this study is able to accomplish its aim to prove non-inferiority of the CMR-based management in patients with stable CAD; the importance of this emerging modality may further increase.ClinicalTrials.gov, identifier: NCT02580851 . Registered on 14 October 2015. Unique Protocol ID: 237/11.

SUBMITTER: Buckert D

PROVIDER: S-EPMC5534045 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial.

Buckert Dominik D Witzel Simon S Cieslik Maciej M Tibi Raid R Rottbauer Wolfgang W Bernhardt Peter P

Trials 20170728 1

<h4>Background</h4>Current guidelines for the diagnosis and management of patients with stable coronary artery disease (CAD) recommend functional stress testing for risk stratification prior to revascularization procedures. Cardiac magnetic resonance imaging (CMR) is a modality of choice for stress testing because of its capability to detect myocardial ischemia sensitively and specifically. Nevertheless, evidence from randomized trials evaluating a CMR-based management of stable CAD patients in ...[more]

PMID: 28754155

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Project description:Perfusion-cardiovascular magnetic resonance (CMR) is generally accepted as an alternative to SPECT to assess myocardial ischemia non-invasively. However its performance vs gated-SPECT and in sub-populations is not fully established. The goal was to compare in a multicenter setting the diagnostic performance of perfusion-CMR and gated-SPECT for the detection of CAD in various populations using conventional x-ray coronary angiography (CXA) as the standard of reference.In 33 centers (in US and Europe) 533 patients, eligible for CXA or SPECT, were enrolled in this multivendor trial. SPECT and CXA were performed within 4 weeks before or after CMR in all patients. Prevalence of CAD in the sample was 49% and 515 patients received MR contrast medium. Drop-out rates for CMR and SPECT were 5.6% and 3.7%, respectively (ns). The study was powered for the primary endpoint of non-inferiority of CMR vs SPECT for both, sensitivity and specificity for the detection of CAD (using a single-threshold reading), the results for the primary endpoint were reported elsewhere. In this article secondary endpoints are presented, i.e. the diagnostic performance of CMR versus SPECT in subpopulations such as multi-vessel disease (MVD), in men, in women, and in patients without prior myocardial infarction (MI). For diagnostic performance assessment the area under the receiver-operator-characteristics-curve (AUC) was calculated. Readers were blinded versus clinical data, CXA, and imaging results.The diagnostic performance (= area under ROC = AUC) of CMR was superior to SPECT (p = 0.0004, n = 425) and to gated-SPECT (p = 0.018, n = 253). CMR performed better than SPECT in MVD (p = 0.003 vs all SPECT, p = 0.04 vs gated-SPECT), in men (p = 0.004, n = 313) and in women (p = 0.03, n = 112) as well as in the non-infarct patients (p = 0.005, n = 186 in 1-3 vessel disease and p = 0.015, n = 140 in MVD).In this large multicenter, multivendor study the diagnostic performance of perfusion-CMR to detect CAD was superior to perfusion SPECT in the entire population and in sub-groups. Perfusion-CMR can be recommended as an alternative for SPECT imaging.ClinicalTrials.gov, Identifier: NCT00977093.

Dataset Information

Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial.

Publications

Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial.

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