Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography
|ClinicalTrials.gov Identifier: NCT00474565|
Recruitment Status : Withdrawn (Suspended failure to follow Conflict of Interest Management Plan)
First Posted : May 17, 2007
Last Update Posted : September 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Procedure: Placement of an aortic root pigtail catheter.||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Contrast-Enhanced Coronary Artery and Coronary Artery Bypass Graft Imaging Using Aortic Root Catheter Injection With Computed Tomographic Angiography (CTA)|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||December 2008|
Procedure: Placement of an aortic root pigtail catheter.
- Coronary artery diameters and degree of stenosis are assessed and compared between conventional cath angio and new CTA study. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474565
|United States, Michigan|
|William Beaumont Hospital, 3601 West 13 Mile Road|
|Royal Oak, Michigan, United States, 48073|
|Study Director:||Amr Abbas, M.D.||William Beaumont Hospitals|
|Study Chair:||Kostaki G. Bis, M.D.||William Beaumont Hospitals|
|Principal Investigator:||Nishit Choksi, MD||William Beaumont Hospitals|