search
Back to results

Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography

Primary Purpose

Coronary Artery Disease

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placement of an aortic root pigtail catheter.
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Catheter,, Aortic root injection,, low dose contrast injection,, coronary artery angiogarm and, coronary artery bypass graft imaging.

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • William Beaumont Hospital, 3601 West 13 Mile Road

Outcomes

Primary Outcome Measures

Coronary artery diameters and degree of stenosis are assessed and compared between conventional cath angio and new CTA study.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2007
Last Updated
September 19, 2012
Sponsor
William Beaumont Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT00474565
Brief Title
Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography
Official Title
Contrast-Enhanced Coronary Artery and Coronary Artery Bypass Graft Imaging Using Aortic Root Catheter Injection With Computed Tomographic Angiography (CTA)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Suspended failure to follow Conflict of Interest Management Plan
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Catheter,, Aortic root injection,, low dose contrast injection,, coronary artery angiogarm and, coronary artery bypass graft imaging.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Placement of an aortic root pigtail catheter.
Intervention Description
Seldinger technique for placement of catheter.
Primary Outcome Measure Information:
Title
Coronary artery diameters and degree of stenosis are assessed and compared between conventional cath angio and new CTA study.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Provided informed consent. Evaluation by a Cardiology Division staff or Cardiology nurse clinician. Exclusion Criteria: Patient is currently enrolled in another related research study. Less than 18 years of age. Pregnant patients. Abnormal renal function with creatinine equal to or greater than 1.6 mg/dl or those subjects requiring dialysis. Patients with chronic obstructive pulmonary disease or heart-failure with cardiac ejection-fraction less than 30%. Patients with known sensitivity to beta-blockers (Lopressor) or have asthma. Patients receiving an abnormally large volume of contrast media during cardiac catheterization (> 200cc)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Abbas, M.D.
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kostaki G. Bis, M.D.
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nishit Choksi, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital, 3601 West 13 Mile Road
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17449736
Citation
Kumar A, Bis KG, Shetty A, Vyas A, Anderson A, Balasubramaniam M, O'Neill W, Stein W. Aortic root catheter-directed coronary CT angiography in swine: coronary enhancement with minimum volume of iodinated contrast material. AJR Am J Roentgenol. 2007 May;188(5):W415-22. doi: 10.2214/AJR.06.0945.
Results Reference
background

Learn more about this trial

Coronary Artery and Coronary Artery Bypass Graft Imaging Using a Specialized Catheter and Computed Tomography

We'll reach out to this number within 24 hrs