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NCT00294853 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official title:
MDCT Calcium Score of Heart Transplanted Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00294853
Other study ID # S-05099
Secondary ID
Status Completed
Phase N/A
First received February 21, 2006
Last updated July 3, 2011
Start date December 2005
Est. completion date June 2007

Study information
Verified date April 2008
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• MDCT calcium score

Locations
Country Name City State
Norway Rikshospitalet-Radiumhospitalet HF Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Calcium score at the date of examination
Secondary Coronary stenoses found on coronary angiography at the date of examination
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