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Chronic Kidney FailureNCT00694824

Vascular Calcification's Risk Factors in Haemodialysis Patients

An observational study of Chronic Kidney Failure and Inflammation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
253 participants
Where
1 siteItaly
Study dates
Nov 2004to Jun 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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;
Show all 9Show fewer
  • Paget's disease;
  • Bisphosphonate therapy.
  • Inflammation active process

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Nhephrology Dialysis Transplantation Unit St.Orsola University Hospital

    Bologna, 40100

Other trials in Italy

About this study

Official title: Traditional and Not Traditional Risk Factors in Appearance and Progression of Vascular Calcification in Haemodialysis Patients.

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.

Read the detailed description

Cardiovascular diseases (CVD) are the main causes of death and hospitalization in patients affected by ESRD . The risk of death from CVD is already detectable in the early steps of chronic renal failure and it is from 20 to 30 times higher than in the general population. In ESRD patients the traditional risk factors for CVD do not offer a satisfactory explanation for such high mortality and morbidity rate. Among them, calcium-phosphate imbalance, inflammation, dialysis age, anaemia, hyperhomocysteinemia, oxidative stress, malnutrition, high lipoprotein levels and endothelial dysfunction have been considered (4).

Recently more attention has been paid to calcium phosphate imbalance involved either in the presence or the progression of vascular calcification (VC) in ESRD patients. Multiple factors have been noticed to contribute to VC other than mineral metabolism: the use of calcium-based phosphate binders, diabetes, aging, inflammation, cytokines and BMI.

Indeed it is now believed that arterial calcification is an active process that involves the phenotypic transformation of vascular smooth muscle cells (VSMC) into bone-forming osteoblast (ob)-like cells that are capable of expressing and/or release bone matrix proteins that are necessary to support the calcification process: OPG, RANKL, OPN, fetuin A and MGP. Several stimuli, first of all mineral changes have been shown to induce o modulate this phenotypic transformation. Indeed the expression and secretion of the above-mentioned proteins is regulated by several molecules such as TGF β, peroxisome proliferator-activated receptors (PPAR) γ, tumor necrosis factor (TNF) α.

Calcification develops at two sites in arterial wall, the intima and the media layers: 1)intimal calcification is frequent in advanced stages of atherosclerosis and is associated with plaque rupture and occlusion of the vessel;2)calcification of media layer, or Mockenberg's sclerosis, is observed in both capacitance vessels and in muscular vessels, it causes arterial stiffness and an high pulse pressure, and is an independent risk factor for mortality of ESRD patients.

Both types of calcifications have an important impact in terms of morbidity and mortality in patients with ESRD especially if the calcification pattern affects the coronary arteries.

It is often difficult to evaluate if the calcification process is mainly located in the intima, in the media or in both. New imaging techniques have recently been used in order to reliably detect and objectively measure the extent of vascular calcification. These techniques include the use of electron beam computed tomography (EBCT) and MSCT to quantify coronary artery calcification (CAC).

The degree of calcification within the coronary arteries is measured to obtain a calcium score. Recently, several studies have analyzed the correlation between VC inhibitors and promoters and both cardiovascular disease and VC . In particular, these studies have analysed the role of fetuin A, MGP, OPG, OPN. Just few studies involved uremic patients and they considered only some of these inhibitory factors individually.

The aim of our study is to evaluate in a cohort of 253 patients, the possible associations of CAC score assessed by MSCT with risk factors of VC.

We selected 253 chronic hemodialysis patients 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 started dialysis from at least 6 months at the beginning of the study. All the patients are considered for gender, age on starting dialysis, months of hemodialysis, length of the period starting from the chronic renal failure onset to the beginning of dialysis, BMI, blood arterial pressure, tobacco abuse.

The mean age is 62.5 ± 13.5 years, the mean dialysis age is 41.6 ± 62.8 months. For each patient a blood sample is 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 metabolism 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. The period of exposure to a calcium phosphate product major than 55 mg/dl is also evaluated in all the patients (days CaxP>55). For this measure the maximum phosphate value is considered, for those patients who assume calcium based phosphate binders the measure of calcium phosphate product is obtained considering the period of maximum oral assumption of these drugs. Furthermore the calcium phosphate product is assessed monthly, in the period of dialysis before the beginning of the study, and the times when the measure exceeded 55 mg/dl (n CaxP >55) are recorded.

In the same way is assessed the period of exposure to a phosphate concentration > 6 mg/dl and the times when the marker exceeded 6 mg/dl.

The kind of phosphate binders is recorded focusing on the different associations between the drugs commercially available. The cardiovascular status of the patient is more strictly defined with a score ranging from 0 to 2 for each patient: 0 is the absence of any cardiovascular event in the patient clinical history, 1 as one VC event, 2 as two or more cardiovascular event. As regards the cardiovascular diseases screening, it is evaluated as follows: presence or absence of ischemic cardiomyopathy, cerebral or peripheral vasculopathy. Coronary artery disease was checked by means of one of the following parameters: 1) previous documentation of acute myocardial infarction; 2) symptomatic VC events in the clinical history confirmed by a positive treadmill test; 3) coronary artery stenosis more than 50% in one of the three major coronary vessels documented by an angiographic study. Cerebrovascular disease was investigated by one of the following criteria: 1) a previous ictus cerebri; b) carotid vessel stenosis more than 50% documented by a Doppler exam. Peripheral vascular disease was assessed by the evidence of claudication intermittens, previous surgical procedure, angiographic or Doppler documentation of significative stenosis in abdominal, iliac and femoral vessels.

All the patients undergo to MSCT for the determination of coronary vascular calcification and the assessment of the calcium score. Instrumental evaluation of coronary vascular calcification and the quantification of the coronary calcium score is obtained by means of Somatom Sensation 16 Cardiac (Siemens Farcheim, Germany), the calcium score was assessed by means of a specific software (Syngo Ca-score, Siemens) according to the Agatston system (18).

Patients are also grouped by means of member of cardiovascular events and by means of serum biochemistry for bone turnover to assess if any difference might emerge. A further group of patients was obtained for BMI dividing patients with BMI < 18.5, with BMI between 18.5 and 30 and over 30 to consider any possible difference of calcium score.

Keywords
Coronary artery calcification, calcium score, (TGF) b1,, fetuin A, osteoprotegerin (OPG), fibroblast growth factor (FGF) 23,, matrix gla protein (MGP), hemodialysis patients
Medical subject headings
Kidney Failure, Chronic, Inflammation, Vascular Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00694824
Study groupRoleWhat they receive
ANot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2008 (estimated)
  2. Study startNov 2004
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00694824
Sponsor's protocol ID
CVAS-INT-02
Status last verified
Mar 2021
First submitted
9 Jun 2008
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15385656
  • 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.

    PubMed 15375022
  • 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.

    PubMed 14981617
  • Giachelli CM. Vascular calcification mechanisms. J Am Soc Nephrol. 2004 Dec;15(12):2959-64. doi: 10.1097/01.ASN.0000145894.57533.C4.

    PubMed 15579497
  • 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.

    PubMed 17200044
  • 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.

    PubMed 16502129
  • 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.

    PubMed 15564564
  • 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.

    PubMed 10648668
  • 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.

    PubMed 12939386
  • 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.

    PubMed 10816185
  • 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.

    PubMed 11849871
  • 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.

    PubMed 8604709
  • 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.

    PubMed 11641313
  • 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.

    PubMed 2407762
  • 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.

    PubMed 18080808

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Failure and Inflammation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00694824, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

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