Overview

This trial is active, not recruiting.

Conditions arterial occlusive diseases, coronary disease, heart diseases, myocardial ischemia, vascular diseases, arteriosclerosis, ischemia, coronary artery disease
Treatments 320 volume detector computed tomography, other: multidetector computed tomography - 320 detectors
Phase phase 3
Sponsor Johns Hopkins University
Collaborator Toshiba America Medical Systems, Inc.
Start date December 2009
End date September 2011
Trial size 444 participants
Trial identifier NCT00934037, Core320

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 corresponding myocardium perfusion defect in a patient with suspected coronary artery disease compared with conventional coronary angiography and single photon emission computed tomography myocardium perfusion imaging.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose diagnostic
Arm
(Other)
Single Arm study. All patients underwent combined CT Angiography and Myocardial Perfusion.
320 volume detector computed tomography
Single Arm Study. All patients undergo Volume (Multidetector) CT.
other: multidetector computed tomography - 320 detectors Aquilion ONE CT scanner
Multidetector computed tomography angiography

Primary Outcomes

Measure
Diagnostic accuracy of volume (multi-detector) computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in a patient with suspected coronary artery disease.
time frame: 30-60 Days

Secondary Outcomes

Measure
Diagnostic accuracy of volume computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding territorial myocardium perfusion defects in a vessel of a patient with suspected CAD.
time frame: 30-60 Days
The combination of biomarkers and CT imaging obtained at baseline is superior to imaging or biomarkers alone in the i.d. of patients who will undergo subsequent coronary revascularization, and/or develop a major coronary event within 2 years.
time frame: 5 Years
Compare the relative diagnostic accuracy of 320 CT angiography vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by QCA
time frame: 30-60 Days
Compare the relative diagnostic accuracy of 320 CT perfusion vs SPECT in predicting at least one ≥ 50% coronary stenosis detected by quantitative conventional angiography.
time frame: 30-60 Days

Eligibility Criteria

Male or female participants from 45 years up to 85 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Multi Center Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Computed Tomography
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 to evaluate the diagnostic accuracy of multi-detector computed tomography using 320 detectors for identifying coronary artery luminal stenosis and corresponding myocardium perfusion defects in patients with suspected coronary artery disease. The primary analysis will be a comparison of the diagnostic capability of the combination of quantitative 320-MDCT angiography and quantitative perfusion imaging to the combination of conventional coronary angiography and SPECT myocardial perfusion imaging at the patient level. A positive patient will be defined as having at least one vessel with a ≥ 50% diameter stenosis defined by quantitative coronary angiography and a corresponding positive SPECT territorial myocardial perfusion defect.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.