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MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification

A Case-control Study of MicroRNAs a Potential Biomarkers for Coronary Artery Calcification (CAC) - An Additional Substudy to Determine the Relationship Between CAC and Bone Mineral Density and Markers of Bone Metabolism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01992848
Enrollment
45
Registered
2013-11-25
Start date
2013-11-30
Completion date
2016-08-31
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification, Coronary Artery Disease, Osteoporosis, Osteopenia

Brief summary

Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with atherosclerotic plaque burden and cardiovascular mortality. Mechanisms underlying isolated CAC have not been as yet been fully explained. MicroRNAs (miRNAs), known to act as regulators of gene expression, have also emerged as powerful biomarkers in the diagnosis and prognosis of cardiovascular disorders and may be used in the detection of CAC. We aim to investigate the potential for a microRNA-signature in patients with CAC by performing a prospective, case-controlled study to identify pathways associated with CAC in humans. Previous research has demonstrated an inverse relationship between CAC and bone mineral density (BMD), suggesting that these processes may be linked. In a further substudy we plan to define the relationship between CAC and BMD as well as a number of markers of bone metabolism.

Detailed description

Patients will be prospectively enrolled whilst attending for elective coronary CT (computed tomography) angiography including a coronary calcium score, at the Royal Surrey County Hospital. Data regarding demographic and clinical characteristics of patients will be collected. Peripheral venous blood sampling will take place on this occasion. Coronary artery calcification scores will be estimated by a Radiologist using default software. Patients eligible for the bone metabolism substudy will be required to attend the University of Surrey for peripheral Quantitative Computed Tomography (pQCT) of bone mineral composition of the radius. In the intervening period we will ask them to complete a 4-day food diary and wear a UV dosimeter, the latter to assess typical UV exposure, for one week.

Interventions

40ml venous blood sampling will be undertaken during participants' attendance for CT coronary angiography (the latter being performed as part of routine clinical investigation).

OTHER4-day food diary
OTHER1 week UV dosimeter

To be worn on outerwear for one week week prior to attendance for pQCT

RADIATIONPeripheral Quantitative Computed Tomography of the radius

To be performed within one month of attendance for CT coronary angiography

Sponsors

University of Surrey
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Patient is able to provide written, informed consent

Exclusion criteria

* Age \> 65 years * Diabetes mellitus * Glomerular filtration rate ≤ 60 ml/min * Abnormal serum calcium * History or clinical features of cardiac failure * Systemic inflammatory disease * Peripheral vascular disease * Previous history of percutaneous coronary intervention (PCI) * Previous history of coronary artery bypass grafting (CABG) * Previous history of reno-vascular disease * Active infection * Active malignancy Additional clinical

Design outcomes

Primary

MeasureTime frame
A miRNA signature in the presence and absence of coronary artery calcification (CAC)12 months

Secondary

MeasureTime frame
mRNA(messenger RNA) targets of identified miRNAs in the presence and absence of CAC12 months
Bone Mineral Density (BMD) in the presence and absence of CAC12 months
Markers of bone metabolism in the presence and absence of CAC to include: serum 25-hydroxy vitamin D, 1,25-dihydroxy vitamin D, serum calcium, albumin, parathyroid hormone, C-terminal telopeptide/CTX, and lipid profile.12 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026