Key result
AQUAMARINE-CKD tests whether CMR-guided care improves cardiovascular outcomes over standard stress testing in high-risk CKD.
Why the study?
Patients with chronic kidney disease at high risk for coronary artery disease may have limited benefit from computed tomography coronary angiography due to contrast nephropathy and decreased diagnostic accuracy from coronary calcifications, and the clinical use of cardiac magnetic resonance imaging for this population has not been robustly evaluated.
RCT (n=524)
Open-label with blinded endpoint evaluation
Dynamic allocation using minimization method (1:1)
Yes
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Background Although screening for coronary artery disease (CAD) using computed tomography coronary angiography in patients with stable chest pain has been reported to be beneficial, patients with chronic kidney disease (CKD) might have limited benefit due to complications of contrast agent nephropathy and decreased diagnostic accuracy as a result of coronary artery calcifications. Cardiac magnetic resonance (CMR) has emerged as a novel imaging modality for detecting coronary stenosis and high-risk coronary plaques without contrast media that is not affected by coronary artery calcification. However, clinical use of this technology has not been robustly evaluated. Methods AQUAMARINE-CKD is an open parallel-group prospective multicenter randomized controlled trial of 524 patients with CKD at high risk for CAD estimated based on risk factor categories for a Japanese urban population (Suita score) recruited from 6 institutions. Participants will be randomized 1:1 to receive CMR examination that includes non-contrast T1-weighted imaging and coronary magnetic angiography (CMR group) or standard examinations that include stress myocardial scintigraphy (control group). Randomization will be conducted using a web-based system to ensure allocation concealment and incorporate minimization. The primary outcome is a composite of death from CAD, all-cause death, nonfatal myocardial infarction, nonfatal ischemic stroke, ischemia-driven unplanned coronary intervention (percutaneous coronary intervention, coronary bypass surgery, or hospitalization for unstable angina pectoris). Discussion This is the first study to look at the implementation of CMR in an outcome-focused patient care pathway. This study will have major implications for the management of patients with CKD at high risk for CAD. Trial registration: Japan Registry of Clinical Trials (jRCT) number 1052210075. Registered on September 10, 2021, http://apps.who.int/trialsearch/ListBy.aspx?
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Noguchi et al. (2022) conducted an RCT in Suspected coronary artery disease with chronic kidney disease (n=524). Cardiac magnetic resonance (non-contrast T1-weighted imaging and coronary magnetic angiography) vs. Standard examinations including stress myocardial scintigraphy was evaluated on Composite of cardiovascular events at 1 year (all-cause death, death from cardiovascular disease, nonfatal myocardial infarction, nonfatal ischemic stroke, ischemia-driven unplanned coronary intervention, or hospitalization for unstable angina pectoris). The AQUAMARINE-CKD trial is a study protocol designed to determine whether a strategy utilizing cardiac magnetic resonance improves clinical outcomes compared to standard stress testing in patients with chronic kidney disease at high risk for coronary artery disease.
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