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Comparison of Coronary CT With IVUS in Heart Transplant Population

This study has been withdrawn prior to enrollment.
(Difficult recruitment -)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589524
First received: December 21, 2007
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Heart Transplantation
 Device: Computed tomography (CT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589524

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

No publications provided

Responsible Party: Amir Lerman, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00589524     History of Changes
Other Study ID Numbers: 06-007193
Study First Received: December 21, 2007
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
blocked arteries
narrowing arteries
IVUS
CT

ClinicalTrials.gov processed this record on October 17, 2012