Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146887
Status:
UNKNOWN
Last Update Posted:
2006-11-07
First Post:
2005-09-04
Brief Title:
Comparison of Coronary CT Angiography to Invasive Coronary Angiography
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
A Trial Comparing the Sensitivity and Specificity of Coronary Angiography With Coronary CT Angiography
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the trial is to investigate the accuracy of coronary CT compared to the conventional gold standard cardiac catheterization
Detailed Description:
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
1 CABG or stent implantation in the past
2 Atrial fibrillation
3 Contraindication for beta blockers
1 Obstructive pulmonary disease
2 Severe peripheral vascular disease
3 Sick sinus syndrome or AV block greater than 1st degree
4 Systolic blood pressure below 100 mm Hg
4 Renal disease or other conditions that might increase the risk of contrast nephropathy diabetes mellitus SLE paraproteinemia malignancy liver disease
5 Allergy to contrast material
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 BPMs will be given 25 mg of metoprolol PO 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 16x075 mm slice thickness 1 mm reconstructed at increments of 05 mm rotation time 042 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 4-5mmsec 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 lumendiameter 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 patients 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
Equal phase mode multi-position which allows viewing of a number of different cuts of the heart all at the same cardiac phase
Equal position mode multi-phase which allows viewing of the same cuts of the heart in different phases The Cardiac Axes Positioning feature provides an easy way to orient the heart to common cardiac views including short axis vertical long axis and horizontal axis
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 eg AP caudal and AP cranial are at the operators 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
1 Basic individual transverse sections
2 Maximal intensity projections with at least 3 of the following views that are compatible with angiogram RAO LAO and spider
3 Multiplanar reformation
4 Three dimensional 3D displays
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 Simsons disk method to calculate cardiac function
1 CABG or stent implantation in the past
2 Atrial fibrillation
3 Contraindication for beta blockers
1 Obstructive pulmonary disease
2 Severe peripheral vascular disease
3 Sick sinus syndrome or AV block greater than 1st degree
4 Systolic blood pressure below 100 mm Hg
4 Renal disease or other conditions that might increase the risk of contrast nephropathy diabetes mellitus SLE paraproteinemia malignancy liver disease
5 Allergy to contrast material
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 BPMs will be given 25 mg of metoprolol PO 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 16x075 mm slice thickness 1 mm reconstructed at increments of 05 mm rotation time 042 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 4-5mmsec 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 lumendiameter 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 patients 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
Equal phase mode multi-position which allows viewing of a number of different cuts of the heart all at the same cardiac phase
Equal position mode multi-phase which allows viewing of the same cuts of the heart in different phases The Cardiac Axes Positioning feature provides an easy way to orient the heart to common cardiac views including short axis vertical long axis and horizontal axis
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 eg AP caudal and AP cranial are at the operators 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
1 Basic individual transverse sections
2 Maximal intensity projections with at least 3 of the following views that are compatible with angiogram RAO LAO and spider
3 Multiplanar reformation
4 Three dimensional 3D displays
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 Simsons disk method to calculate cardiac function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Non applicable | None | None | None |