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NCT Number: NCT01992848

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

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.

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Key information

Conditions

Coronary Artery Calcification Arterial Occlusive Diseases Arteriosclerosis Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Metabolic Diseases Musculoskeletal Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Osteopenia Osteoporosis Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Surrey County Hospital, Guildford, Surrey, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria for our sub-study are:

  • Regular use of sunbeds
  • A sun holiday one month prior to or plans for sun holiday within the study
  • Use of vitamin D supplements
  • Consumption of alcohol above recommended levels
  • Pregnancy or planned pregnancy
  • Use of a veil

Treatment and study plan

Venous blood sampling

Other

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

4-day food diary

Other

1 week UV dosimeter

Other

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

Peripheral Quantitative Computed Tomography of the radius

Radiation

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

Primary outcomes

  1. A miRNA signature in the presence and absence of coronary artery calcification (CAC)

    Time frame: 12 months

Secondary outcomes

  1. mRNA(messenger RNA) targets of identified miRNAs in the presence and absence of CAC

    Time frame: 12 months

  2. Bone Mineral Density (BMD) in the presence and absence of CAC

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 25, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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