Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01574963
Status:
UNKNOWN
Last Update Posted:
2012-04-10
First Post:
2012-04-04
Brief Title:
Graz Osteoprotegerin as a Risk Factor GORF Study
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2012-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 OPGRANKLRANK 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 25OH vitamin D Vit D 125OH vitamin D parathormone iPTH endocrine parameters related to vascular damage eg 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 arginineglycine 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 markers 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
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 25OH vitamin D Vit D 125OH vitamin D parathormone iPTH endocrine parameters related to vascular damage eg 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 arginineglycine 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 markers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None