NCT00294853

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

April 1, 2008

First QC Date

February 21, 2006

Last Update Submit

July 3, 2011

Conditions

Coronary Artery Disease

Keywords

Coronary calcium scoreCoronary artery diseaseCardiac transplantationCoronary calcium score in heart transplanted patientsCoronary artery disease in heart transplanted patients

Outcome Measures

Primary Outcomes (1)

  • Calcium score

    at the date of examination

Secondary Outcomes (1)

  • Coronary stenoses found on coronary angiography

    at the date of examination

Interventions

MDCT calcium scorePROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Heart transplanted patient
  • Aged 18 or above.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF

Oslo, 0020, Norway

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Anne Günther, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

December 1, 2005

Study Completion

June 1, 2007

Last Updated

July 6, 2011

Record last verified: 2008-04

Locations

NO(1)