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

NCT00474565 | Withdrawn Phase 1 DMC

• 1 other identifier: 2005-156
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Catheter,; Aortic root injection,; low dose contrast injection,; coronary artery angiogarm and; coronary artery bypass graft imaging.

Outcome Measures

Primary Outcomes (1)

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

  1 year

Interventions

Placement of an aortic root pigtail catheter. PROCEDURE

Seldinger technique for placement of catheter.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital, 3601 West 13 Mile Road

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

• 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.

  PMID: 17449736 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Amr Abbas, M.D.

  Corewell Health East

  STUDY DIRECTOR

• Kostaki G. Bis, M.D.

  Corewell Health East

  STUDY CHAIR

• Nishit Choksi, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

US (1)