|- candidate number||1852|
|- NTR Number||NTR535|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2005|
|- Secondary IDs||N/A |
|- Public Title||The ''CORE-64'' Study.|
|- Scientific Title||Coronary Evaluation Using Multi-detector Spiral Computed Tomography Angiography using 64 Detectors.|
|- hypothesis||The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a patient with suspected coronary artery disease, is of equal quality compared with conventional coronary angiography.|
|- Healt Condition(s) or Problem(s) studied||Coronary artery stenosis|
|- Inclusion criteria||1. Male or female patients;|
2. age 40 years or greater;
3. suspected or diagnosed coronary artery disease with a clinical indication for coronary angiography and planned coronary angiography within the next 30 days;
4. able to understand and willing to sign the Informed Consent Form.
|- Exclusion criteria||1. Known allergy to iodinated contrast media;|
2. history of contrast-induced nephropathy;
3. history of multiple myeloma or previous organ transplantation;
4. elevated serum creatinine (> 1.5mg/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);
5. evidence of severe symptomatic heart failure (NYHA Class III or IV);
6. known or suspected moderate or severe aortic stenosis;
7. previous coronary artery bypass or other cardiac surgery;
8. coronary artery intervention within the last 6 months;
9. known or suspected intolerance or contraindication to beta-blockers including:
a. known allergy to beta-blockers;
b. history of moderate to severe bronchospastic lung disease (including moderate to severe asthma);
c. severe pulmonary disease (chromic obstructive pulmonary disease);
10. presence of any other history or condition that the investigator feels would be problematic;
11. Body Mass Index > 40.
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2006|
|- planned closingdate||1-jun-2007|
|- Target number of participants||6|
|- Primary outcome||Sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a patient with suspected coronary artery disease, compared with conventional coronary angiography.|
|- Secondary outcome||The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a patient with suspected coronary artery disease compared with conventional coronary angiography.
The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a single coronary vessel, compared with conventional coronary angiography.
The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a single coronary vessel, compared with conventional coronary angiography
The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 50% in a specific proximal coronary segment, compared with conventional coronary angiography
The sensitivity and specificity of MDCTA for identifying coronary artery stenosis ¡Ý 70% in a specific proximal coronary segment, compared with conventional coronary angiography
Predictive ability of MDCTA for cardiovascular clinical events within 6 months and 1 year, compared with conventional coronary angiography.
The diagnostic accuracy of MDCTA for determining the degree of stenosis (continuous variable) per coronary vessel relative to conventional coronary angiography.
The accuracy of on-site versus central reading of MDCTA. |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. A. Roos, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. A. Roos, de|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Toshiba Medical Systems Corporation|
|- Brief summary||Cardiac catheterization with invasive coronary angiography has been, and continues to be the gold standard for determining the presence or absence of significant coronary luminal stenosis. However, due to the inherent risks involved with this invasive procedure (such as stroke, myocardial infarction, death or need for emergency surgical intervention; major complication rate of 1-2%), and high cost, non-invasive assessments of coronary artery disease are usually preferred. Currently available functional methods of assessment, such as stress echocardiography and nuclear stress testing are limited in their inability to provide direct anatomic information with limited sensitivity and specificity for CAD. |
Advances in computed tomography, and specifically Multi-Detector Computed Tomography (MDCT) have provided the ability to image the coronary artery anatomy non-invasively. Early studies comparing MDCT (4-slice technology) and invasive coronary angiography were limited by highly selected populations, small sample size, high percentage of non-assessable segments, and widely variable sensitivity and specificity results. However, recent advances in spatial and temporal resolution have greatly improved the image quality provided by MDCT. Further techniques of ECG-gating, increased detector rows, and segmented reconstruction have continued to improve the potential diagnostic capability of this technology. The newest generation MDCT (32-64 detector rows) scanners are able to provide 0.5mm slice thickness with spatial resolution ranging from 0.35-0.5mm. Thus, the purpose of this study is to compare the diagnostic utility of MDCTA compared with conventional coronary angiography for the diagnosis of clinically significant coronary artery disease.
|- Main changes (audit trail)|
|- RECORD||24-nov-2005 - 1-dec-2009|