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Vascular Calcification's Risk Factors in Haemodialysis Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
University of Bologna
Information provided by:
St. Orsola Hospital
A not randomized , cross sectional study will be done to determine the possible association of coronary artery calcification (CAC) score assessed by multirow spiral computed tomography (MSCT) with specific and non specific uremic factor of vascular calcification.

Chronic Kidney Failure Inflammation Vascular Calcification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Traditional and Not Traditional Risk Factors in Appearance and Progression of Vascular Calcification in Haemodialysis Patients.

Resource links provided by NLM:

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • The aim of our study was to evaluate in a cohort of 253 patients, the possible associations of CAC score assessed by MSCT with risk factors of VC. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
For each patient a blood sample was drawn to check the basal values of hemoglobin, hematocrit, folates, vitamin B12, C reactive protein, PTH, calcium, phosphorus, albumin, alkaline phosphatase, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, uric acid, fibrinogen, homocysteine. To better understand the mineral methabolism TGFb1, fetuin A, OPG, FGF 23, OPN and MGP will be checked. The values for each patient will be the median of 4 determinations, each sample was drawn before the midweek dialysis session.

Enrollment: 253
Study Start Date: November 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
253 chronic hemodialysis patients were selected among those undergoing hemodialysis at the Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital, Bologna, Italy between April 2003 and March 2008. All the patients have started dialysis from at least 6 months at the beginning of the study.

Inclusion Criteria:

  • All the patients have started dialysis from at least 6 months

Exclusion Criteria:

  • Recent infectious or cardiovascular disease in the last month before the enrollment in the study;
  • Malignancies;
  • Active bleeding;
  • Therapy with ace inhibitors or angiotensin II blocking drugs;
  • Enrollment in other study protocols;
  • Bone fractures in the last year;
  • Paget's disease;
  • Bisphosphonate therapy.
  • Inflammation active process
  Contacts and Locations
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): NCT00694824

Nhephrology Dialysis Transplantation Unit St.Orsola University Hospital
Bologna, Italy, 40100
Sponsors and Collaborators
St. Orsola Hospital
University of Bologna
Study Director: Sergio Stefoni, Professor St.Orsola Malpighi University Hospital
  More Information


Responsible Party: Professor Sergio Stefoni, Nephrology Dialysis and Renal Transplantation Unit
ClinicalTrials.gov Identifier: NCT00694824     History of Changes
Other Study ID Numbers: CVAS-INT-02
First Submitted: June 9, 2008
First Posted: June 11, 2008
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by St. Orsola Hospital:
Coronary artery calcification
calcium score
(TGF) b1,
fetuin A
osteoprotegerin (OPG)
fibroblast growth factor (FGF) 23,
matrix gla protein (MGP)
hemodialysis patients

Additional relevant MeSH terms:
Renal Insufficiency
Vascular Calcification
Kidney Failure, Chronic
Pathologic Processes
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic