Comparison of Coronary CT With IVUS in Heart Transplant Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00589524
Recruitment Status : Withdrawn (Difficult recruitment -)
First Posted : January 9, 2008
Last Update Posted : January 16, 2012
Information provided by:
Mayo Clinic

Brief Summary:
To compare results of Intravascular Ultrasound (which occurs during cardiac catheterization) with Computed Tomography (CT) scan to detect blockages or narrowing of the arteries that feed the heart. These will be studied in the cardiac transplant population.

Condition or disease Intervention/treatment Phase
Heart Transplantation Device: Computed tomography (CT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Non-invasive Coronary CT With IVUS for the Detection of Coronary Artery Vasculopathy in a Cardiac Transplant Population
Study Start Date : November 2007
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Computed tomography (CT)
    Computed tomography (CT), as performed by Dual Source Computed Tomography (DSCT)(Siemens Medical Solutions Germany) to be conducted no sooner than 3 days before or after cardiac catheterization, but with 3 months of the cardiac cath.
    Other Name: DSCT Scanner, 4D scanner serial number 60011

Primary Outcome Measures :
  1. To determine if Computed Tomography (CT) of the arteries that feed the heart is more sensitive than Intravascular Ultrasound (IVUS) which is performed during cardiac catheterization [ Time Frame: within 3 months of cardiac cath with IVUS ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Heart transplant patients coming to the Cardiac Cath Lab for their yearly angiogram which includes intravascular ultrasound (IVUS)

Exclusion Criteria:

  • Patients with a history of allergic reactions to contrast material Creatine >1.5 Clinical or hemodynamic instability Those who are unable to consent for enrollment into the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00589524

Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Amir Lerman, MD Mayo Clinic

Responsible Party: Amir Lerman, M.D., Mayo Clinic Identifier: NCT00589524     History of Changes
Other Study ID Numbers: 06-007193
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: January 16, 2012
Last Verified: January 2012

Keywords provided by Mayo Clinic:
blocked arteries
narrowing arteries