Cardiovascular DiseasesNCT04388943
Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
This project will examine the diagnosis and prognosis of patients with cardiovascular disease in hospital in- and outpatients and compare their characteristics with normal controls from the community. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Observation
- How many people
- 9,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2010to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited from secondary care, inpatient and outpatient departments.
Who may be able to join
- All outpatients and inpatients with cardiovascular disease, of either gender
- Aged 18-90 years old
- Examples of conditions include: coronary artery disease, heart failure, heart attacks (myocardial infarction), valve disease, cardiac surgery, dysrhythmias (including atrial fibrillation), aneurysms, embolism, strokes, peripheral vascular disease, hypertension (and its complications, such as left ventricular hypertrophy) or those presenting with chest pain
- Healthy volunteers
- Aged 18-90 years old
- From the community without cardiovascular or other diseases
Who cannot join
- Any patient who is unable to give consent
- Any patient with non-cardiovascular comorbidity likely to cause death within 6 months
- Patients know to be infected with HIV, Hepatitis B or any other agent posing an infection risk from unfixed material
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Leicester
Leicester
Emma P Beeston
About this study
This project will examine the diagnosis and prognosis of patients with cardiovascular disease in hospital in- and outpatients and compare their characteristics with normal controls from the community. The cardiovascular diseases studied include coronary artery disease, heart failure, heart attacks, valve disease, cardiac surgery, dysrhythmias, aneurysms, embolism, strokes, peripheral vascular disease and hypertension. Current methods for diagnosis and predicting outcome in patients are limited and may lack accuracy. This study will collect clinical details, and blood and urine samples from patients for analysis of proteins, chemicals and genetic biomarkers which will enable an examination of the pathological mechanisms involved in cardiovascular disease. The data will also be used to improve diagnosis and also improve prediction of outcome in patients (future clinical events such as death, further hospitalisation with cardiovascular disease and the effects of any therapy given to the patients). In this way, we can develop accurate ways of assessing a patient's condition and how it could be effectively managed. The study will last for 20 years.
- Being tested
- Observation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Physiological Measurements Patient reported questionnaire Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To improve understanding of disease mechanisms in cardiovascular disease
The principal objective is to improve upon our understanding of disease mechanisms in cardiovascular disease, using plasma and urine proteins or chemicals and a patient's genetic makeup, which may impact on the diagnosis and assessment of prognosis of cardiovascular disease.
Measured: 20 Years
Secondary outcomes (1)
To improve prediction of responses to different treatments, using blood proteins or chemicals and a patient's genetic makeup
Secondary objectives include predicting response to different treatments (which would include drugs, devices) using blood proteins or chemicals and a patient's genetic makeup, after appropriate matching by propensity scoring. Plus, assessing whether biomarkers in stool or other tissue can discern the presence and severity of coronary artery disease.
Measured: 20 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start17 Jun 2010
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester
- Responsible party
- Sponsor
- Investigators
- Nilesh J Samani, Professor, Principal investigator, NIHR Leicester Biomedical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388943
- Sponsor's protocol ID
- 14022
- Status last verified
- Jun 2026
- First submitted
- 13 May 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
- ClinicalTrials.gov ID
- NCT04388943
- Acronym / sponsor ID
- 14022
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,500 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester
- Study start
- 17 Jun 2010 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 May 2020 (actual)
- 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.
This project will examine the diagnosis and prognosis of patients with cardiovascular disease in hospital in- and outpatients and compare their characteristics with normal controls from the community. The cardiovascular diseases studied include coronary artery disease, heart failure, heart attacks, valve disease, cardiac surgery, dysrhythmias, aneurysms, embolism, strokes, peripheral vascular disease and hypertension. Current methods for diagnosis and predicting outcome in patients are limited and may lack accuracy. This study will collect clinical details, and blood and urine samples from patients for analysis of proteins, chemicals and genetic biomarkers which will enable an examination of the pathological mechanisms involved in cardiovascular disease. The data will also be used to improve diagnosis and also improve prediction of outcome in patients (future clinical events such as death, further hospitalisation with cardiovascular disease and the effects of any therapy given to the patients). In this way, we can develop accurate ways of assessing a patient's condition and how it could be effectively managed. The study will last for 20 years.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Observation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited from secondary care, inpatient and outpatient departments.
Key inclusion criteria (6 listed)
- All outpatients and inpatients with cardiovascular disease, of either gender
- Aged 18-90 years old
- Examples of conditions include: coronary artery disease, heart failure, heart attacks (myocardial infarction), valve disease, cardiac surgery, dysrhythmias (including atrial fibrillation), aneurysms, embolism, strokes, peripheral vascular disease, hypertension (and its complications, such as left ventricular hypertrophy) or those presenting with chest pain
- Healthy volunteers
- Aged 18-90 years old
Key exclusion criteria (3 listed)
- Any patient who is unable to give consent
- Any patient with non-cardiovascular comorbidity likely to cause death within 6 months
- Patients know to be infected with HIV, Hepatitis B or any other agent posing an infection risk from unfixed material
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 |
|---|---|---|
| ObservationPhysiological Measurements Patient reported questionnaire Blood sampling | Other | 1 |
Primary outcome
To improve understanding of disease mechanisms in cardiovascular disease
Time frame: 20 Years
The principal objective is to improve upon our understanding of disease mechanisms in cardiovascular disease, using plasma and urine proteins or chemicals and a patient's genetic makeup, which may impact on the diagnosis and assessment of prognosis of cardiovascular disease.
1 secondary outcome
To improve prediction of responses to different treatments, using blood proteins or chemicals and a patient's genetic makeup
Time frame: 20 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Nilesh J Samani, Professor principal investigator
NIHR Leicester Biomedical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by University Hospitals, Leicester at 1 site 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma P Beeston (0116 204 4738, emma.beeston@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To improve understanding of disease mechanisms in cardiovascular disease (time frame: 20 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.