Multi Detector-Row Computed Tomography (MDCT) Calcium Score of Heart Transplanted Patients

July 3, 2011 updated by: Oslo University Hospital

MDCT Calcium Score of Heart Transplanted Patients

The purpose of the study is to determine if calcium score can be used as a predictor of coronary artery disease in heart transplanted patients, as it is used in non-transplanted persons.

Study Overview

Status

Completed

Conditions

Coronary Artery Disease

Intervention / Treatment

Procedure: MDCT calcium score

Detailed Description

Several studies have shown that a negative calcium score is a strong independent negative predictor of coronary artery disease (CAD). CAD in heart transplants (HTx) differs from CAD lesions in native hearts. The aim of this study is to see if there is a similar relation between coronary artery calcium and CAD in transplanted hearts as in native hearts.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0020
    - Rikshospitalet-Radiumhospitalet HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Heart transplanted patient
Aged 18 or above.

Exclusion Criteria:

Pregnancy
Atrial fibrillation
Severe heart failure New York Heart Association (NYHA) class IV
Severe pulmonary disease making the patient unable to hold his/her breath for more than 10 seconds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Calcium score Time Frame: at the date of examination	at the date of examination

Secondary Outcome Measures

Outcome Measure	Time Frame
Coronary stenoses found on coronary angiography Time Frame: at the date of examination	at the date of examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria