Back to resultsAdenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adenosine stress dynamic CT perfusion
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Men and women patients, with age ranging 40-80.
- Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications
- Patients who are willing to sign the informed consent form
Exclusion Criteria:
- 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)
- Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min
- Unstable or uncooperative patients
- Limited life expectancy due to cancer or end-stage renal or liver disease
- Evidence of severe symptomatic heart failure (NYHA Class III or IV)
- Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT perfusion group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01680081
Brief Title
Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment of target subjects and difficulty registering subjects
Study Start Date
January 30, 2012 (Actual)
Primary Completion Date
July 11, 2016 (Actual)
Study Completion Date
July 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT perfusion group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Adenosine stress dynamic CT perfusion
Primary Outcome Measure Information:
Title
Diagnostic accuracy of stress induced CT perfusion
Description
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.
Time Frame
10-30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women patients, with age ranging 40-80.
Suspected coronary artery disease who are supposed to undergo invasive coronary angiography with appropriate clinical indications
Patients who are willing to sign the informed consent form
Exclusion Criteria:
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)
Contraindication of MRI Claustrophobia Metallic hazards Pacemaker implant eGFR<30 ml/min
Unstable or uncooperative patients
Limited life expectancy due to cancer or end-stage renal or liver disease
Evidence of severe symptomatic heart failure (NYHA Class III or IV)
Previous myocardial infarction, coronary artery intervention, coronary artery bypass surgery, or other cardiac surgery
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Adenosine-induced Stress Dynamic Myocardial Perfusion Imaging With Dual-source CT
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