Status:
COMPLETED
Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Toshiba America Medical Systems, Inc.
Conditions:
Arterial Occlusive Diseases
Coronary Disease
Eligibility:
All Genders
45-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying the combination of coronary artery stenosis ≥ 50% and a corre...
Detailed Description
The Combined Coronary angiography and myocardial perfusion imaging using 320 detectors computed tomography (CORE-320) was designed as a prospective, multi-center, international, blinded study designed...
Eligibility Criteria
Inclusion
- Male or female patients, age 45-85. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
- Suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography; and planned coronary angiography within the next 60 days.
- Able to understand and willing to sign the Informed Consent Form.
Exclusion
- Known allergy to iodinated contrast media.
- History of contrast-induced nephropathy.
- History of multiple myeloma or previous organ transplantation.
- Elevated serum creatinine (\> 1.5 mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula.
- Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block).
- Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis.
- Previous coronary artery bypass or other cardiac surgery.
- Coronary artery intervention within the last 6 months.
- Known or suspected intolerance or contraindication to beta-blockers including:
- Known allergy to beta-blockers
- History of moderate to severe bronchospastic lung disease (including moderate to severe asthma).
- Severe pulmonary disease (chronic obstructive pulmonary disease).
- Presence of any other history or condition that the investigator feels would be problematic.
- SPECT preformed in non-validated center within 60 days prior to screening.
- SPECT performed within the previous 6 months of screening but \> 60 days.
- SPECT studies performed within 60 days of screening that include rest and stress studies performed using 2 day protocols.
- BMI greater than 40
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT00934037
Start Date
December 1 2009
End Date
September 1 2017
Last Update
September 5 2018
Active Locations (16)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
2
National Heart Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Brigham and Women Hospital
Boston, Massachusetts, United States, 02215