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

April 24, 2017 updated by: University of Surrey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XH
        • The University of Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • The Royal Surrey County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A miRNA signature in the presence and absence of coronary artery calcification (CAC)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
mRNA(messenger RNA) targets of identified miRNAs in the presence and absence of CAC
Time Frame: 12 months
12 months
Bone Mineral Density (BMD) in the presence and absence of CAC
Time Frame: 12 months
12 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.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Investigators

  • Principal Investigator: Michael Mahmoudi, MBChB PhD, The University of Surrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAP-Calcification

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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