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

NCT01992848 | Completed DMC

• 1 other identifier: MAP-Calcification
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Calcification; Coronary Artery Disease; Osteoporosis; Osteopenia

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (3)

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

  12 months

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

  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.

  12 months

Study Arms (1)

All participants

EXPERIMENTAL

Venous blood sampling 4-day food diary 1 week UV Dosimeter Peripheral Quantitative Computed Tomography of the radius

Other: Venous blood sampling; Other: 4-day food diary; Other: 1 week UV dosimeter; Radiation: Peripheral Quantitative Computed Tomography of the radius

Interventions

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).

All participants

4-day food diary OTHER

All participants

1 week UV dosimeter OTHER

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

All participants

Peripheral Quantitative Computed Tomography of the radius RADIATION

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

All participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Regular use of sunbeds
• A sun holiday one month prior to or plans for sun holiday within the study
• Use of vitamin D supplements

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (2)

The University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

The Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Publications (1)

• Howlett P, Cleal JK, Wu H, Shah N, Horton A, Curzen N, Mahmoudi M. MicroRNA 8059 as a marker for the presence and extent of coronary artery calcification. Open Heart. 2018 Jan 31;5(1):e000678. doi: 10.1136/openhrt-2017-000678. eCollection 2018.

  PMID: 29531756 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Osteoporosis; Bone Diseases, Metabolic

Interventions

Blood Specimen Collection; Diet Records

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Records; Organization and Administration; Health Services Administration

Study Officials

• Michael Mahmoudi, MBChB PhD

  The University of Surrey

  PRINCIPAL INVESTIGATOR

• Chris Fry, BSc PhD

  The University of Surrey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

GB (2)