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Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography
This study is currently recruiting participants.
Verified by William Beaumont Hospitals, June 2008
First Received: May 16, 2007   Last Updated: June 3, 2008   History of Changes
Sponsored by: William Beaumont Hospitals
Information provided by: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00474565
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: Placement of an aortic root pigtail catheter.
Phase I

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Double Blind (Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Contrast-Enhanced Coronary Artery and Coronary Artery Bypass Graft Imaging Using Aortic Root Catheter Injection With Computed Tomographic Angiography (CTA)

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Coronary artery diameters and degree of stenosis are assessed and compared between conventional cath angio and new CTA study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Placement of an aortic root pigtail catheter.
    Seldinger technique for placement of catheter.
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients that have an abnormal nuclear medicine heart scan and are already scheduled for cardiac catheterization for evaluation of coronary artery disease or disease of coronary artery bypass grafts will be asked to participate in this trial.
  2. Provided informed consent.
  3. Evaluation by a Cardiology Division staff or Cardiology nurse clinician.

Exclusion Criteria:

  1. Patient is currently enrolled in another related research study.
  2. Less than 18 years of age.
  3. Pregnant patients.
  4. Abnormal renal function with creatinine equal to or greater than 1.6 mg/dl or those subjects requiring dialysis.
  5. Patients with chronic obstructive pulmonary disease or heart-failure with cardiac ejection-fraction less than 30%.
  6. Patients with known sensitivity to beta-blockers (Lopressor) or have asthma.
  7. Patients receiving an abnormally large volume of contrast media during cardiac catheterization (> 200cc)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00474565

Contacts
Contact: Amr Abbas, M.D. 248-898-5243 aabbas@beaumont.edu
Contact: Kostaki G. Bis, M.D. 248-551-4484 kbis@beaumont.edu

Locations
United States, Michigan
William Beaumont Hospital, 3601 West 13 Mile Road Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Amr Abbas, M.D.     248-898-5243     aabbas@beaumont.edu    
Contact: Kostaki Bis, M.D.     248-551-4484     kbis@beaumont.edu    
Principal Investigator: Amr Abbas, M.D.            
Sub-Investigator: Kostaki G. Bis, M.D.            
Sub-Investigator: Anil N. Shetty, Ph.D.            
Sub-Investigator: Michael Gallagher, M.D.            
Sub-Investigator: Gilbert Raff, M.D.            
Sub-Investigator: John Erogul, M.D.            
Sub-Investigator: Mazen Shoukfeh, M.D.            
Sub-Investigator: Maher Rabah, M.D.            
Sub-Investigator: Dominic Marsalese, M.D.            
Sub-Investigator: Aaron Berman, M.D.            
Sub-Investigator: John Stephens, M.D.            
Principal Investigator: Nishit Choksi, MD            
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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
  More Information

Publications:
Responsible Party: William Beaumont Hospital ( Nishit Choksi, M.D./Principal Investigator/Interventional Cardiologist )
Study ID Numbers: HIC-2005-156
Study First Received: May 16, 2007
Last Updated: June 3, 2008
ClinicalTrials.gov Identifier: NCT00474565     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Catheter,
Aortic root injection,
low dose contrast injection,
coronary artery angiogarm and
coronary artery bypass graft imaging.

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009