JRCT ID: jRCT1052210075
Registered date:05/09/2021
Accuracy of coronary MR plaque imaging in patient with chronic kidney disease associated with coronary artery disease
Basic Information
Recruitment status | Recruiting |
---|---|
Health condition(s) or Problem(s) studied | coronary artery disease, ischemic stroke, hypertension, peripheral arterial disease, diabetes mellit |
Date of first enrollment | 08/12/2023 |
Target sample size | 524 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Magnetic resonance coronary plaque imaging and magnetic resonance angiography |
Outcome(s)
Primary Outcome | A composite of death from coronary heart disease and all cause death, nonfatal myocardial infarction, ischemia-driven unplanned coronary intervention (percutaneous coronary intervention or coronary bypass surgery, or hospitalization for unstable angina pectoris) |
---|---|
Secondary Outcome | 1) Incidence of composite cardiovascular events after 144 weeks of research testing (long-term prognosis) 2) Cost-effectiveness analysis 3) Comparison of management status (prescription rate of secondary prevention drugs for coronary artery disease and attainment of control goals for blood pressure, lipids, and diabetes; additional imaging tests (myocardial SPECT and cardiac MRI); and PCI or coronary artery bypass) after cardiac MRI and conventional testing 4) Complication rate of coronary artery HIP in high-risk patients for primary prevention of coronary artery disease with a Suita score of 66 or higher (Plaque to Myocardium Ratio (PMR) value of 1.1 or higher, and coronary artery HIP complication rate of 1.3 or higher) |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | < 85age old |
Gender | Both |
Include criteria | Patients with stage 3 or higher chronic kidney disease with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2 with suspected coronary artery disease or angina pectoris |
Exclude criteria | Patients with suspected acute coronary syndrome Patients who have had myocardial infarction within 3 months Patients with contraindication for MRI examination Patients undergoing hemodialysis or peritoneal dialysis Patients with a resting pulse rate of 80 beats per minute or higher, or patients with chronic atrial fibrillation Patients who cannot give their consent. Patients who have difficulty in understanding the contents of this study and who are judged to be inappropriate by the physician in charge. |
Related Information
Primary Sponsor | Noguchi Teruo |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development (AMED) |
Secondary ID(s) |
Contact
Public contact | |
Name | Teruo Noguchi |
Address | 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565 Osaka Japan 564-8565 |
Telephone | +81-6-6170-1070 |
tnoguchi@ncvc.go.jp | |
Affiliation | National Cerebral and Cardiovascular Center |
Scientific contact | |
Name | Teruo Noguchi |
Address | 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565 Osaka Japan 564-8565 |
Telephone | +81-6-6170-1070 |
tnoguchi@ncvc.go.jp | |
Affiliation | National Cerebral and Cardiovascular Center |