Comparison of Coronary CT With IVUS in Heart Transplant Population

Heart Transplantation Clinical Trial

Official title:

Comparison of Non-invasive Coronary CT With IVUS for the Detection of Coronary Artery Vasculopathy in a Cardiac Transplant Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00589524
• Other study ID #: 06-007193
• Status: Withdrawn
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 12, 2012
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: January 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		within 3 months of cardiac cath with IVUS	No