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

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ClinicalTrials.gov Identifier: NCT01992848
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Surrey

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.

Condition or disease Intervention/treatment
Coronary Artery Calcification Coronary Artery Disease Osteoporosis Osteopenia Other: Venous blood sampling Other: 4-day food diary Other: 1 week UV dosimeter Radiation: Peripheral Quantitative Computed Tomography of the radius

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : November 2013
Primary Completion Date : August 2015
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Arm Intervention/treatment
Experimental: All participants

Venous blood sampling 4-day food diary

1 week UV Dosimeter Peripheral Quantitative Computed Tomography of the radius

Other: Venous blood sampling
40ml venous blood sampling will be undertaken during participants' attendance for CT coronary angiography (the latter being performed as part of routine clinical investigation).
Other: 4-day food diary Other: 1 week UV dosimeter
To be worn on outerwear for one week week prior to attendance for pQCT
Radiation: Peripheral Quantitative Computed Tomography of the radius
To be performed within one month of attendance for CT coronary angiography



Primary Outcome Measures :
  1. A miRNA signature in the presence and absence of coronary artery calcification (CAC) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992848


Locations
United Kingdom
The University of Surrey
Guildford, Surrey, United Kingdom, GU2 7XH
The Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Sponsors and Collaborators
University of Surrey
Investigators
Principal Investigator: Michael Mahmoudi, MBChB PhD The University of Surrey
Study Director: Chris Fry, BSc PhD The University of Surrey

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01992848     History of Changes
Other Study ID Numbers: MAP-Calcification
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Osteoporosis
Calcinosis
Bone Diseases, Metabolic
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders