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

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ClinicalTrials.gov Identifier: NCT00294853
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: MDCT calcium score Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MDCT Calcium Score of Heart Transplanted Patients
Study Start Date : December 2005
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Calcium score [ Time Frame: at the date of examination ]

Secondary Outcome Measures :
  1. Coronary stenoses found on coronary angiography [ Time Frame: at the date of examination ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294853


Locations
Norway
Rikshospitalet-Radiumhospitalet HF
Oslo, Norway, 0020
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Anne Günther, MD Oslo University Hospital

ClinicalTrials.gov Identifier: NCT00294853     History of Changes
Other Study ID Numbers: S-05099
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: April 2008

Keywords provided by Oslo University Hospital:
Coronary calcium score
Coronary artery disease
Cardiac transplantation
Coronary calcium score in heart transplanted patients
Coronary artery disease in heart transplanted patients

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs