NCT00589524

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

December 21, 2007

Last Update Submit

January 12, 2012

Conditions

Heart Transplantation

Keywords

blocked arteriesnarrowing arteriesIVUSCT

Outcome Measures

Primary Outcomes (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

    within 3 months of cardiac cath with IVUS

Interventions

Computed tomography (CT)DEVICE

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.

Also known as: DSCT Scanner, 4D scanner serial number 60011

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Amir Lerman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 9, 2008

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 16, 2012

Record last verified: 2012-01