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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01680081
Other study ID # 1-2011-0064
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 30, 2012
Est. completion date July 11, 2016

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Adenosine stress dynamic CT perfusion


Locations

Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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