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

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00294853
First received: February 21, 2006
Last updated: July 3, 2011
Last verified: April 2008
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
 Procedure: MDCT calcium score

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MDCT Calcium Score of Heart Transplanted Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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

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

Estimated Enrollment: 240
Study Start Date: December 2005
Estimated Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294853

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

No publications provided

ClinicalTrials.gov Identifier: NCT00294853     History of Changes
Other Study ID Numbers: S-05099
Study First Received: February 21, 2006
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013