Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial
Abstract 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...
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| Format: | Article |
| Language: | English |
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BMC
2022-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06820-w |
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| author | Teruo Noguchi Hideki Ota Naoya Matsumoto Yoshiaki Morita Akira Oshita Eiji Kawasaki Tomohiro Kawasaki Kensuke Moriwaki Shingo Kato Kazuki Fukui Tomoya Hoshi Hiroaki Watabe Tomoaki Kanaya Yasuhide Asaumi Yu Kataoka Fumiyuki Otsuka Kensuke Takagi Shuichi Yoneda Kenichiro Sawada Takamasa Iwai Hideo Matama Satoshi Honda Masashi Fujino Hiroyuki Miura Kunihiro Nishimura Kei Takase |
| author_facet | Teruo Noguchi Hideki Ota Naoya Matsumoto Yoshiaki Morita Akira Oshita Eiji Kawasaki Tomohiro Kawasaki Kensuke Moriwaki Shingo Kato Kazuki Fukui Tomoya Hoshi Hiroaki Watabe Tomoaki Kanaya Yasuhide Asaumi Yu Kataoka Fumiyuki Otsuka Kensuke Takagi Shuichi Yoneda Kenichiro Sawada Takamasa Iwai Hideo Matama Satoshi Honda Masashi Fujino Hiroyuki Miura Kunihiro Nishimura Kei Takase |
| author_sort | Teruo Noguchi |
| collection | DOAJ |
| description | Abstract 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, the 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 a 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. The primary outcome is a composite of cardiovascular events at 1 year after study examinations: all-cause death, death from CAD, nonfatal myocardial infarction, nonfatal ischemic stroke, and ischemia-driven unplanned coronary intervention (percutaneous coronary intervention or coronary bypass surgery). Discussion If the combination of T1-weighted imaging and coronary magnetic angiography contributes to the risk assessment of CAD in patients with CKD, this study will have major clinical implications for the management of patients with CKD at high risk for CAD. Trial registration Japan Registry of Clinical Trials (jRCT) 1,052,210,075. Registered on September 10, 2021. |
| first_indexed | 2024-04-13T17:21:09Z |
| format | Article |
| id | doaj.art-23f8a512e04b4914be955bf4309a4ea1 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T17:21:09Z |
| publishDate | 2022-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-23f8a512e04b4914be955bf4309a4ea12022-12-22T02:37:57ZengBMCTrials1745-62152022-10-0123111010.1186/s13063-022-06820-wClinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trialTeruo Noguchi0Hideki Ota1Naoya Matsumoto2Yoshiaki Morita3Akira Oshita4Eiji Kawasaki5Tomohiro Kawasaki6Kensuke Moriwaki7Shingo Kato8Kazuki Fukui9Tomoya Hoshi10Hiroaki Watabe11Tomoaki Kanaya12Yasuhide Asaumi13Yu Kataoka14Fumiyuki Otsuka15Kensuke Takagi16Shuichi Yoneda17Kenichiro Sawada18Takamasa Iwai19Hideo Matama20Satoshi Honda21Masashi Fujino22Hiroyuki Miura23Kunihiro Nishimura24Kei Takase25Department of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Diagnostic Radiology, Tohoku University HospitalDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Nihon University HospitalDepartment of Radiology, National Cerebral and Cardiovascular CenterDepartment of Cardiology, Ehime Prefectural Imabari HospitalDepartment of Diabetes and Endocrinology, Shin-Koga HospitalCardiovascular and Heart Rhythm Center, Shin-Koga HospitalComprehensive Unit for Health Economic Evidence Review and Decision Support, Research Organization of Science and Technology, Ritsumeikan UniversityDepartment of Cardiovascular Medicine, Kanagawa Cardiovascular and Respiratory CenterDepartment of Cardiovascular Medicine, Kanagawa Cardiovascular and Respiratory CenterCardiovascular Division, Faculty of Medicine, University of TsukubaCardiovascular Division, Faculty of Medicine, University of TsukubaDepartment of Cardiovascular Medicine, Dokkyo Medical University HospitalDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular CenterDepartment of Preventive Medicine and Epidemiology, National Cerebral and Cardiovascular CenterDepartment of Diagnostic Radiology, Tohoku University Graduate School of MedicineAbstract 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, the 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 a 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. The primary outcome is a composite of cardiovascular events at 1 year after study examinations: all-cause death, death from CAD, nonfatal myocardial infarction, nonfatal ischemic stroke, and ischemia-driven unplanned coronary intervention (percutaneous coronary intervention or coronary bypass surgery). Discussion If the combination of T1-weighted imaging and coronary magnetic angiography contributes to the risk assessment of CAD in patients with CKD, this study will have major clinical implications for the management of patients with CKD at high risk for CAD. Trial registration Japan Registry of Clinical Trials (jRCT) 1,052,210,075. Registered on September 10, 2021.https://doi.org/10.1186/s13063-022-06820-wCardiac magnetic resonanceCoronary artery diseaseChronic kidney diseasePlaque imaging |
| spellingShingle | Teruo Noguchi Hideki Ota Naoya Matsumoto Yoshiaki Morita Akira Oshita Eiji Kawasaki Tomohiro Kawasaki Kensuke Moriwaki Shingo Kato Kazuki Fukui Tomoya Hoshi Hiroaki Watabe Tomoaki Kanaya Yasuhide Asaumi Yu Kataoka Fumiyuki Otsuka Kensuke Takagi Shuichi Yoneda Kenichiro Sawada Takamasa Iwai Hideo Matama Satoshi Honda Masashi Fujino Hiroyuki Miura Kunihiro Nishimura Kei Takase Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial Trials Cardiac magnetic resonance Coronary artery disease Chronic kidney disease Plaque imaging |
| title | Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial |
| title_full | Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial |
| title_fullStr | Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial |
| title_full_unstemmed | Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial |
| title_short | Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial |
| title_sort | clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease aquamarine ckd study study protocol for a randomized controlled trial |
| topic | Cardiac magnetic resonance Coronary artery disease Chronic kidney disease Plaque imaging |
| url | https://doi.org/10.1186/s13063-022-06820-w |
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