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Vascular Calcification's Risk Factors in Haemodialysis Patients

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ClinicalTrials.gov Identifier: NCT00694824
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
Sponsor:
Collaborator:
University of Bologna
Information provided by:
St. Orsola Hospital

Brief Summary:
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.

Condition or disease
Chronic Kidney Failure Inflammation Vascular Calcification

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 253 participants
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.
Study Start Date : November 2004
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Group/Cohort
A



Primary Outcome Measures :
  1. 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.


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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.
Criteria

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

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


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

Publications of Results:
Other Publications:

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 Posted: June 11, 2008    Key Record Dates
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:
Inflammation
Renal Insufficiency
Calcinosis
Vascular Calcification
Kidney Failure, Chronic
Pathologic Processes
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic