Coronary Artery Disease Clinical Trial
Verified date | January 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was designed as a prospective multicenter trial to determine the accuracy of combined CT coronary angiography and perfusion imaging, specifically quantitative dynamic perfusion imaging in patients with suspicious coronary artery disease compared conventional coronary angiography and quantitative dynamic perfusion MRI as standard reference.
Status | Terminated |
Enrollment | 51 |
Est. completion date | July 11, 2016 |
Est. primary completion date | July 11, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Men and women patients, with age ranging 40-80. 2. Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications 3. Patients who are willing to sign the informed consent form Exclusion Criteria: 1. Contraindication of CT Known allergy to iodinated contrast media or history of contrast-induced nephropathy Decreased renal function: elevated serum creatinine(>1.5mg/dl) Contraindication to beta-blockers Severe arrhythmia: arterial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) 2. Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min 3. Unstable or uncooperative patients 4. Limited life expectancy due to cancer or end-stage renal or liver disease 5. Evidence of severe symptomatic heart failure (NYHA Class III or IV) 6. Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of stress induced CT perfusion | Diagnostic accuracy of combined stress and rest dynamic CT perfusion and coronary angiography with dual x-ray sources in detection of hemodynamically significant stenosis of coronary artery compared with conventional coronary angiography and perfusion MRI in patients with suspicious coronary artery disease. | 10-30 days |
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