Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474565
Status:
WITHDRAWN
Last Update Posted:
2012-09-21
First Post:
2007-05-16
Brief Title:
Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Contrast-Enhanced Coronary Artery and Coronary Artery Bypass Graft Imaging Using Aortic Root Catheter Injection With Computed Tomographic Angiography CTA
Status:
WITHDRAWN
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspended failure to follow Conflict of Interest Management Plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study relates to a new approach to coronary artery and coronary artery by-pass graft imaging and more particularly to computed tomographic angiography following an aortic root injection of a low amount of contrast up to 30 cc via a percutaneously placed catheter Vanguard DX Medrad Inc positioned in the aortic root
The objective of the study is to show the feasibility of Coronary artery CTA using aortic root injection of contrast compared to the standard invasive cardiac catheterization
The objective of the study is to show the feasibility of Coronary artery CTA using aortic root injection of contrast compared to the standard invasive cardiac catheterization
Detailed Description:
Coronary artery disease remains the leading cause of death worldwide The diagnosis via the gold standard cardiac catheterization remains a time consuming expensive and invasive procedure with some considerable risks In addition there is a significant risk due to cumulative amount of iodinated contrast delivered between 80 - 120 cc in patients who have abnormal renal insufficiency or at a high risk for developing contrast nephropathy Cardiac catheterization specifically involves arterial puncture with a needle usually in the groin or upper extremity through which a guidewire is passed fluoroscopically to the ascending aorta A catheter is then inserted over the guidewire and subsequently the guidewire is removed and iodinated contrast is injected to opacify the aorta or coronary arteries As such there are different kinds of catheters that are used to engage either the right or left native coronary arteries or by-pass vein grafts This procedure requires separate injections into the coronary arteries or by-pass grafts which can induce arrhythmias require over one hour of procedural time requires larger bore catheters exposes the physician and patient to ionizing radiation and subjects the patient with coronary artery disease to contrast induced nephropathy especially in cases requiring higher loads of iodinated contrast
Of the noninvasive techniques the most common limiting factor when employing IV-enhanced CTA is the underlying blood pool which also enhances when contrast-enhanced protocols are employed using a peripheral intravenous contrast injection route This results in a frequent obscuration of the native coronary arteries Reproducible enhancement of the distal and tributary anatomy is another pitfall with IV-enhanced coronary CTA In addition the amount of contrast agent required is similar to that amount required during invasive coronary angiography As such the method of the present study provides an imaging concept of the coronary arteries employing a catheter device in conjunction with computed tomography CT imaging machine that will enable a reduction of the total amount of dye delivered to the patient
Of the noninvasive techniques the most common limiting factor when employing IV-enhanced CTA is the underlying blood pool which also enhances when contrast-enhanced protocols are employed using a peripheral intravenous contrast injection route This results in a frequent obscuration of the native coronary arteries Reproducible enhancement of the distal and tributary anatomy is another pitfall with IV-enhanced coronary CTA In addition the amount of contrast agent required is similar to that amount required during invasive coronary angiography As such the method of the present study provides an imaging concept of the coronary arteries employing a catheter device in conjunction with computed tomography CT imaging machine that will enable a reduction of the total amount of dye delivered to the patient
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