Comparison of Coronary CT With IVUS in Heart Transplant Population

This study is currently recruiting participants.

Verified by Mayo Clinic, March 2009

First Received: December 21, 2007 Last Updated: March 17, 2009 History of Changes

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00589524

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)

MedlinePlus related topics: CT Scans Heart Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Comparison of Non-Invasive Coronary CT With IVUS for the Detection of Coronary Artery Vasculopathy in a Cardiac Transplant Population

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 ]

Estimated Enrollment:	50
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:

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.

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

Contacts

Contact: Rebecca E. Nelson, CCRC

507-255-5123 ext 8388

nelson.rebecca@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
rochester, Minnesota, United States, 55905
Contact: Rebecca E. Nelson, CCRC 507-255-5123 ext 8388 nelson.rebecca@mayo.edu
Principal Investigator: Amir Lerman, MD

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Amir Lerman, MD

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Clinic ( Amir Lerman, M.D. )
Study ID Numbers:	06-007193
Study First Received:	December 21, 2007
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00589524 History of Changes
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 May 07, 2009