Coronary Artery CalcificationNCT01992848
MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification
A study testing Venous blood sampling, 4-day food diary and 1 week UV dosimeter in people with Coronary Artery Calcification and Coronary Artery Disease, run by University of Surrey at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Calcification, Coronary Artery Disease, Osteoporosis
- What is being tested?
- Venous blood sampling, 4-day food diary and 1 week UV dosimeter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient is able to provide written, informed consent
Who cannot join
- Age > 65 years
- Diabetes mellitus
- Glomerular filtration rate ≤ 60 ml/min
- Abnormal serum calcium
- History or clinical features of cardiac failure
- Systemic inflammatory disease
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The University of Surrey
Guildford, Surrey, GU2 7XH
The Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
About this study
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
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.
Read the 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.
- Being tested
- Venous blood sampling, 4-day food diary, 1 week UV dosimeter, Peripheral Quantitative Computed Tomography of the radius
- Medical subject headings
- Coronary Artery Disease, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood samplingOther
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 diaryOther
1 week UV dosimeterOther
To be worn on outerwear for one week week prior to attendance for pQCT
Peripheral Quantitative Computed Tomography of the radiusRadiation
To be performed within one month of attendance for CT coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Venous blood sampling 4-day food diary
1 week UV Dosimeter Peripheral Quantitative Computed Tomography of the radius Receives: Other: Venous blood sampling; Other: 4-day food diary; Other: 1 week UV dosimeter; Radiation: Peripheral Quantitative Computed Tomography of the radius |
What is being measured
The primary outcome is the main question the study is designed to answer.
A miRNA signature in the presence and absence of coronary artery calcification (CAC)
Measured: 12 months
Secondary outcomes (3)
mRNA(messenger RNA) targets of identified miRNAs in the presence and absence of CAC
Measured: 12 months
Bone Mineral Density (BMD) in the presence and absence of CAC
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Mahmoudi, MBChB PhD, Principal investigator, The University of SurreyChris Fry, BSc PhD, Study director, The University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992848
- Sponsor's protocol ID
- MAP-Calcification
- Status last verified
- Apr 2017
- First submitted
- 23 Oct 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29531756
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01992848
- Acronym / sponsor ID
- MAP-Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Venous blood sampling, Other: 4-day food diary, Other: 1 week UV dosimeter, Radiation: Peripheral Quantitative Computed Tomography of the radiusVenous blood sampling 4-day food diary 1 week UV Dosimeter Peripheral Quantitative Computed Tomography of the radius |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Patient is able to provide written, informed consent
Key exclusion criteria (19 listed)
- Age > 65 years
- Diabetes mellitus
- Glomerular filtration rate ≤ 60 ml/min
- Abnormal serum calcium
- History or clinical features of cardiac failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampling40ml venous blood sampling will be undertaken during participants' attendance for CT coronary angiography (the latter being performed as part of routine clinical investigation). | Other | All participants |
| 4-day food diary | Other | All participants |
| 1 week UV dosimeterTo be worn on outerwear for one week week prior to attendance for pQCT | Other | All participants |
| Peripheral Quantitative Computed Tomography of the radiusTo be performed within one month of attendance for CT coronary angiography | Radiation | All participants |
Primary outcome
A miRNA signature in the presence and absence of coronary artery calcification (CAC)
Time frame: 12 months
3 secondary outcomes
mRNA(messenger RNA) targets of identified miRNAs in the presence and absence of CAC
Time frame: 12 months
Bone Mineral Density (BMD) in the presence and absence of CAC
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 29531756Howlett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mahmoudi, MBChB PhD principal investigator
The University of Surrey
Chris Fry, BSc PhD study director
The University of Surrey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous blood sampling, 4-day food diary and 1 week UV dosimeter in people with Coronary Artery Calcification and Coronary Artery Disease, run by University of Surrey at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A miRNA signature in the presence and absence of coronary artery calcification (CAC) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01992848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017; AzTrials last refreshed its copy on 26 Oct 2026.