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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

MDCT calcium score

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary calcium score, Coronary artery disease, Cardiac transplantation, Coronary calcium score in heart transplanted patients, Coronary artery disease in heart transplanted patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rikshospitalet-Radiumhospitalet HF

Outcomes

Primary Outcome Measures

Calcium score

Secondary Outcome Measures

Coronary stenoses found on coronary angiography

Full Information

NCT ID

NCT00294853

First Posted

February 21, 2006

Last Updated

July 3, 2011

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00294853

Brief Title

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

Official Title

MDCT Calcium Score of Heart Transplanted Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Oslo University Hospital

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary calcium score, Coronary artery disease, Cardiac transplantation, Coronary calcium score in heart transplanted patients, Coronary artery disease in heart transplanted patients

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

MDCT calcium score

Primary Outcome Measure Information:

Title

Calcium score

Time Frame

at the date of examination

Secondary Outcome Measure Information:

Title

Coronary stenoses found on coronary angiography

Time Frame

at the date of examination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne Günther, MD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rikshospitalet-Radiumhospitalet HF

City

Oslo

ZIP/Postal Code

0020

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

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