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Vascular Calcification's Risk Factors in Haemodialysis Patients

This study has been completed.
Sponsor:
Collaborator:
University of Bologna
Information provided by:
St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT00694824
First received: June 9, 2008
Last updated: June 10, 2008
Last verified: June 2008
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: June 9, 2008
Last Updated: June 10, 2008
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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:
Calcinosis
Inflammation
Kidney Failure, Chronic
Renal Insufficiency
Calcium Metabolism Disorders
 Metabolic Diseases
Pathologic Processes
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013