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Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study
Dominik Buckert1, Simon Witzel2, Maciej Cieslik2
1Department of Internal Medicine II, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. dominik.buckert@uni-ulm.de.
Insights
This study compares cardiac magnetic resonance imaging (CMR) stress testing to angiography for managing stable coronary artery disease (CAD). It aims to show CMR is a non-inferior diagnostic tool, potentially improving patient outcomes.
Area of Science:
- Cardiology
- Medical Imaging
- Clinical Trials
Background:
- Current guidelines recommend functional stress testing for stable coronary artery disease (CAD) risk stratification.
- Cardiac magnetic resonance imaging (CMR) offers sensitive and specific detection of myocardial ischemia.
- Limited randomized trial evidence exists comparing CMR-based management to angiography-based approaches in stable CAD.
Purpose of the Study:
- To evaluate the non-inferiority of a management strategy guided by adenosine stress CMR compared to standard angiography in patients with stable CAD.
- To assess the impact of CMR-guided management on cardiac death, myocardial infarction, and unplanned invasive procedures over 3 years.
- To compare symptom burden and quality of life between the two management strategies.
Main Methods:
- Prospective, 1:1 randomized trial enrolling patients with stable CAD and indications for angiography.
- Group 1: Diagnostic coronary angiography and guideline-directed revascularization.
- Group 2: Adenosine stress CMR; positive ischemia leads to coronary angiography.
Main Results:
- Primary endpoint: composite of cardiac death and non-fatal myocardial infarction at 3-year follow-up.
- Secondary endpoints include unplanned invasive procedures, symptom burden (Seattle Angina Questionnaire), and quality of life.
- Sample size calculated to demonstrate non-inferiority of the CMR-based approach.
Conclusions:
- If non-inferiority is demonstrated, this study will support the increased importance of CMR in managing stable CAD.
- Findings may influence future clinical guidelines for stable CAD diagnosis and treatment.
- The study provides crucial data on the comparative effectiveness of CMR versus angiography in a real-world setting.
Background:
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.
Methods/Design:
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.
Discussion:
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.
Trial Registration:
ClinicalTrials.gov, identifier: NCT02580851 . Registered on 14 October 2015. Unique Protocol ID: 237/11.
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