Comparison of Coronary CT Angiography to Invasive Coronary Angiography
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|ClinicalTrials.gov Identifier: NCT00146887|
Recruitment Status : Unknown
Verified August 2005 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : September 7, 2005
Last Update Posted : November 7, 2006
|First Submitted Date ICMJE||September 4, 2005|
|First Posted Date ICMJE||September 7, 2005|
|Last Update Posted Date||November 7, 2006|
|Study Start Date ICMJE||January 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||CT sensitivity and specificity|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00146887 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of Coronary CT Angiography to Invasive Coronary Angiography|
|Official Title ICMJE||A Trial Comparing the Sensitivity and Specificity of Coronary Angiography With Coronary CT Angiography|
|Brief Summary||The purpose of the trial is to investigate the accuracy of coronary CT compared to the conventional "gold standard" cardiac catheterization.|
40 Patients who are scheduled to undergo coronary angiogram will be recruited at Mount Scopus and Ein Kerem. Patients will be excluded if they have one or more of the following conditions
Coronary CT angiography: Patient preparation and data acquisition Pre-procedure preparation: Following informed consent, patients will be scheduled to undergo coronary CT angiography within 7 days prior to coronary angiogram. Patients with heart rates above 75 BPM's will be given 25 mg of metoprolol P.O. 60-90 minutes before the test. If the patient does not reach heart rate below 75, administration of additional IV metoprolol may be considered by a cardiologist.
Scanning protocol: Images will be obtained using collimation of 16x0.75 mm, slice thickness 1 mm reconstructed at increments of 0.5 mm, rotation time 0.42 seconds, kVp 140 and mAs 400. Prior to scanning, 120-150cc of non-ionic contrast material will be injected to a peripheral vein at a rate of 4-5mm/sec. Images will be obtained with ECG gating.
Post processing: The Cardiac CT Angiography software (Philips, Cleveland, USA) allows extraction of the coronary tree from the heart and analysis of the arterial lumen. This application operates on the volume rendered image of the heart. After isolation of the coronary tree, the software enables the selection of an artery for quantitative analysis of its lumen. The obtained information includes presentation of the artery in panoramic views, visualization of the artery and adjacent vascular anatomy in Maximum Intensity Projection (MIP) mode for anatomical enhancement, and cross sectional views, perpendicular to the artery axis for free lumen/diameter analysis, thus providing a tool to estimate stenosis severity and dimensions. Using color mapping, plaque composition is delineated to distinguish calcified from soft plaque.
The Cardiac Review software (Philips, Cleveland, USA) provides detailed views of the patient's cardiac cycle and, using Cine function, allows dynamic viewing of the heart. Using the scanning protocol specified above, cardiac image raw data and an ECG signal are recorded simultaneously. The images are then reconstructed retrospectively in phases. Phases are defined according to the percentage of cardiac contraction, and a series of images is named according to the phase during which they are acquired. The heart can be viewed in any desired cut plane, using the Multi-Planar Formatting (MPR) application.
The Cardiac Review software provides 2 modes of viewing the heart images (Multi Views):
The Cine feature allows viewing the heart in motion. MPR allows scrolling through various portions of the heart while viewing in the cine mode. The sequence can be saved as an AVI format movie.
Angiography: Within 7 days following coronary CT angiography patients will undergo cardiac catheterization with at least the following views: anterior-posterior (AP), right anterior oblique (RAO) cranial, RAO caudal, left anterior oblique (LAO) cranial, and LAO caudal. Additional views (e.g. AP caudal and AP cranial) are at the operator's discretion.
During the hospitalization all patients will undergo echocardiography to assess wall motion abnormalities.
Image interpretation The data will be analyzed in using the following strategies
The coronary tree will be divided into the following segments which correlate to conventional angiogram segments Proximal RCA, 2-mid RCA, 3-distal RCA and PL, 4-PDA, 5-LM, 6-proximal LAD, 7-mid LAD, 8-distal LAD, 9-largest diagonal, 10, proximal CX, 11-Distal CX, 12-largest marginal.
These segments will be evaluated by a consensus reading of a cardiologist and a radiologist for the following parameters: existence of atherosclerosis, existence of calcification, percent narrowing within the following ranges <50%, 50%-70%, 70%-90%, tight. These scorings will be used later for comparison with the angiogram results. The physicians interpreting the CT results will be blinded to the results of the angiogram.
For analysis of myocardial function, an axial image series at the mid ventricular level showing papillary muscles through the entire cardiac cycle will be performed to visually identify the maximal systolic constriction phase and diastolic phase as the images showing the largest and smallest left ventricular cavity area, respectively. The corresponding delay in milliseconds from the R peak of the ECG will be used for image reconstruction. Then, a short and a ling axis reconstructed views will be performed to be analyzed at diastole and systole using Simson's disk method to calculate cardiac function.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Condition ICMJE||Atherosclerosis, Coronary|
|Intervention ICMJE||Procedure: coronary catheterization|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Estimated Study Completion Date||August 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
40 Patients who are scheduled to undergo coronary angiogram will be recruited at Mount Scopus and Ein Kerem
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00146887|
|Other Study ID Numbers ICMJE||21-03.09.04-HMO-CTIL
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Not Provided|
|PRS Account||Hadassah Medical Organization|
|Verification Date||August 2005|
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