Vascular Calcification's Risk Factors in Haemodialysis Patients

NCT00694824 | Completed

• 1 other identifier: CVAS-INT-02
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Failure; Inflammation; Vascular Calcification

Keywords

Coronary artery calcification; calcium score; (TGF) b1,; fetuin A; osteoprotegerin (OPG); fibroblast growth factor (FGF) 23,; matrix gla protein (MGP); hemodialysis patients

Outcome Measures

Primary Outcomes (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.

  5 years

Study Arms (1)

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator

Study Sites (1)

Nhephrology Dialysis Transplantation Unit St.Orsola University Hospital

Bologna, 40100, Italy

Location

Related Publications (22)

• Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.

  PMID: 15385656 BACKGROUND

• Moe SM, Chen NX. Pathophysiology of vascular calcification in chronic kidney disease. Circ Res. 2004 Sep 17;95(6):560-7. doi: 10.1161/01.RES.0000141775.67189.98.

  PMID: 15375022 BACKGROUND

• Goodman WG, London G, Amann K, Block GA, Giachelli C, Hruska KA, Ketteler M, Levin A, Massy Z, McCarron DA, Raggi P, Shanahan CM, Yorioka N; Vascular Calcification Work Group. Vascular calcification in chronic kidney disease. Am J Kidney Dis. 2004 Mar;43(3):572-9. doi: 10.1053/j.ajkd.2003.12.005. No abstract available.

  PMID: 14981617 BACKGROUND

• Giachelli CM. Vascular calcification mechanisms. J Am Soc Nephrol. 2004 Dec;15(12):2959-64. doi: 10.1097/01.ASN.0000145894.57533.C4.

  PMID: 15579497 BACKGROUND

• El-Abbadi M, Giachelli CM. Mechanisms of vascular calcification. Adv Chronic Kidney Dis. 2007 Jan;14(1):54-66. doi: 10.1053/j.ackd.2006.10.007.

  PMID: 17200044 BACKGROUND

• Jono S, Shioi A, Ikari Y, Nishizawa Y. Vascular calcification in chronic kidney disease. J Bone Miner Metab. 2006;24(2):176-81. doi: 10.1007/s00774-005-0668-6.

  PMID: 16502129 BACKGROUND

• Collin-Osdoby P. Regulation of vascular calcification by osteoclast regulatory factors RANKL and osteoprotegerin. Circ Res. 2004 Nov 26;95(11):1046-57. doi: 10.1161/01.RES.0000149165.99974.12.

  PMID: 15564564 BACKGROUND

• Schwarz U, Buzello M, Ritz E, Stein G, Raabe G, Wiest G, Mall G, Amann K. Morphology of coronary atherosclerotic lesions in patients with end-stage renal failure. Nephrol Dial Transplant. 2000 Feb;15(2):218-23. doi: 10.1093/ndt/15.2.218.

  PMID: 10648668 BACKGROUND

• London GM. Cardiovascular calcifications in uremic patients: clinical impact on cardiovascular function. J Am Soc Nephrol. 2003 Sep;14(9 Suppl 4):S305-9. doi: 10.1097/01.asn.0000081664.65772.eb.

  PMID: 12939386 BACKGROUND

• Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider D, Wang Y, Chung J, Emerick A, Greaser L, Elashoff RM, Salusky IB. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med. 2000 May 18;342(20):1478-83. doi: 10.1056/NEJM200005183422003.

  PMID: 10816185 BACKGROUND

• Raggi P, Boulay A, Chasan-Taber S, Amin N, Dillon M, Burke SK, Chertow GM. Cardiac calcification in adult hemodialysis patients. A link between end-stage renal disease and cardiovascular disease? J Am Coll Cardiol. 2002 Feb 20;39(4):695-701. doi: 10.1016/s0735-1097(01)01781-8.

  PMID: 11849871 BACKGROUND

• Braun J, Oldendorf M, Moshage W, Heidler R, Zeitler E, Luft FC. Electron beam computed tomography in the evaluation of cardiac calcification in chronic dialysis patients. Am J Kidney Dis. 1996 Mar;27(3):394-401. doi: 10.1016/s0272-6386(96)90363-7.

  PMID: 8604709 BACKGROUND

• Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42. doi: 10.1161/hy1001.096358.

  PMID: 11641313 BACKGROUND

• Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol. 1990 Mar 15;15(4):827-32. doi: 10.1016/0735-1097(90)90282-t.

  PMID: 2407762 BACKGROUND

• Jahnen-Dechent W, Schafer C, Ketteler M, McKee MD. Mineral chaperones: a role for fetuin-A and osteopontin in the inhibition and regression of pathologic calcification. J Mol Med (Berl). 2008 Apr;86(4):379-89. doi: 10.1007/s00109-007-0294-y. Epub 2007 Dec 15.

  PMID: 18080808 BACKGROUND

• Ix JH, Chertow GM, Shlipak MG, Brandenburg VM, Ketteler M, Whooley MA. Association of fetuin-A with mitral annular calcification and aortic stenosis among persons with coronary heart disease: data from the Heart and Soul Study. Circulation. 2007 May 15;115(19):2533-9. doi: 10.1161/CIRCULATIONAHA.106.682450. Epub 2007 May 7.

  PMID: 17485576 BACKGROUND

• Dhore CR, Cleutjens JP, Lutgens E, Cleutjens KB, Geusens PP, Kitslaar PJ, Tordoir JH, Spronk HM, Vermeer C, Daemen MJ. Differential expression of bone matrix regulatory proteins in human atherosclerotic plaques. Arterioscler Thromb Vasc Biol. 2001 Dec;21(12):1998-2003. doi: 10.1161/hq1201.100229.

  PMID: 11742876 BACKGROUND

• Scatena M, Liaw L, Giachelli CM. Osteopontin: a multifunctional molecule regulating chronic inflammation and vascular disease. Arterioscler Thromb Vasc Biol. 2007 Nov;27(11):2302-9. doi: 10.1161/ATVBAHA.107.144824. Epub 2007 Aug 23.

  PMID: 17717292 BACKGROUND

• Ketteler M, Bongartz P, Westenfeld R, Wildberger JE, Mahnken AH, Bohm R, Metzger T, Wanner C, Jahnen-Dechent W, Floege J. Association of low fetuin-A (AHSG) concentrations in serum with cardiovascular mortality in patients on dialysis: a cross-sectional study. Lancet. 2003 Mar 8;361(9360):827-33. doi: 10.1016/S0140-6736(03)12710-9.

  PMID: 12642050 BACKGROUND

• Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23.

  PMID: 11443763 RESULT

• Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation. 2003 Oct 28;108(17):2154-69. doi: 10.1161/01.CIR.0000095676.90936.80. No abstract available.

  PMID: 14581387 RESULT

• Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016.

  PMID: 14582032 RESULT

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.

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation; Vascular Calcification

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sergio Stefoni, Professor

  St.Orsola Malpighi University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: November 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

IT (1)