Graz Osteoprotegerin as a Risk Factor (GORF) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medical University of Graz.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Daniela Malliga, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01574963
First received: April 4, 2012
Last updated: April 9, 2012
Last verified: April 2012

April 4, 2012
April 9, 2012
July 2010
July 2012   (final data collection date for primary outcome measure)
OSTEOPROTEGERIN (OPG) [ Time Frame: Baseline at time 0 (at the beginning of the study). The participants will be followed for the duration of hospital stay, an expected average of 10 days. ] [ Designated as safety issue: Yes ]
The primary endpoints are the differences between the two groups in serum levels of OPG and RANKL, markers of bone metabolism (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH) vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density.
Same as current
Complete list of historical versions of study NCT01574963 on ClinicalTrials.gov Archive Site
RANKL [ Time Frame: At baseline. The participants will be followed for the duration of hospital stay, an expected average of 10 days. ] [ Designated as safety issue: Yes ]
The primary endpoints are the differences between the two groups in serum levels of OPG and RANKL, markers of bone metabolism (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH) vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density.
Same as current
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Graz Osteoprotegerin as a Risk Factor (GORF) Study
Graz Osteoprotegerin as a Risk Factor (GORF) Study: THE ROLE of OSTEOPROTEGERIN (OPG) and the RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-Kb LIGAND (RANKL) IN PATIENTS REQUIRING SURGERY FOR CORONARY HEART DISEASE

Osteoprotegerin (OPG) is membrane bound in the immune system but can also be produced and secreted almost everywhere in the organism, so that it is mainly available in soluble form. So far, the OPG/RANKL/RANK system has been most intensively studied in bone. The binding of RANKL on its receptor RANK, which is expressed by osteoclasts, activates a number of osteoclastic cell functions. OPG also has a key function in the vascular system. Patients with coronary heart disease (CAD) have elevated OPG serum levels, probably as a sign of ischemic or inflammatory endothelial damage. Elevated OPG levels were also found in patients with advanced heart failure, whereby OPG correlated with pro BNP (brain natriuretic peptide) and was a predictor for cardiovascular morbidity and mortality.

Our prospective cohort study will include 150 men (75 patients requiring surgery for CAD and a control group without coronary heart disease). The primary endpoints are the differences between the two groups in serum levels of OPG and RANKL, markers of bone metabolism (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH) vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density. Metabolomic based biomarkers will be evaluated to explore the mechanisms behind OPG-RANKL linked CVD damage. In the patients further studies of the mRNA expression of OPG, RANKL, TRAP5b, arginine:glycine amidinotransferase (AGAT) and osteocalcin in bone (sternum sliver) and vascular wall (aorta, internal thoracic artery and the great saphenous vein) will be performed.

A further study endpoint is the analysis of a causal coincidence between osteoporosis and CAD and the discrimination of possible key factors in the two entities. These will be determined by the correlation between the above-mentioned markers in serum and the expression in different vessels and in bone tissue.

In addition to analysis of the degree of vascular sclerosis, the mineral content of the bone will also be analyzed in a subpopulation with quantitative backscattered electron imaging (qBEI) related to the degree of vascular sclerosis and bone mineral density. The ultimate goal of the analysis is the discrimination of the most sensitive predictive marker(s) for diagnosis and outcome of patients with CAD for the purpose of early diagnosis and primary prevention of the disease.

CAD and osteoporosis are increasingly prevalent diseases that overlap. In both entities, OPG plays a role not only in pathogenesis but also as an outcome predictor. We aim to study the relevance of OPG concentration in serum but also in the vessel wall and the bone.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Male patients above 40 years of age presenting with symptomatic CAD and scheduled for a coronary artery bypass graft (CABG) are eligible for the study. The control group includes male patients scheduled for elective surgery other than cardiac procedures.

Prevalent OPG and RANKL Excession in Patients With CAD
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  • CAD Patients
    Patients suffering from CAD requiring coronary artery bypass grafting
  • Control Patients
    Patients without CAD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients above 40 years of age presenting with symptomatic CAD and scheduled for a coronary artery bypass graft (CABG) are eligible for the study. The control group includes male patients scheduled for elective surgery other than cardiac procedures.

Exclusion Criteria:

  • Exclusion criteria are a second indication for heart surgery, chronic renal disease with a glomerular filtration rate < 30ml/min, advanced liver disease (AST, ALT, GGT > 3fold upper limit of normal), history of malignancy within the last 5 years and ongoing osteoprotective treatment.
Male
40 Years to 90 Years
No
Contact: Daniela Malliga, MD 0043 316 385 ext 80651 daniela-eugenia.martin@medunigraz.at
Contact: Doris Wagner, MD 0043 316 385 ext 80651 doris.wagner@medunigraz.at
Austria
 
NCT01574963
GORF 2.0
Yes
Daniela Malliga, MD, Medical University of Graz
Medical University of Graz
Medical University of Vienna
Principal Investigator: Daniela Malliga, MD Medical University of Graz, Department of Surgery, Division for Cardiac Surgery
Study Director: Astrid Fahrleitner-Pammer, Prof. Medical University of Graz, Department of Internal Medicine, Division for Endocrinology and Metabolism
Study Chair: Doris Wagner, MD Medical University of Graz, Department of Surgery, Division for Transplantation
Medical University of Graz
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP