- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388943
Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
June 10, 2026 updated by: University Hospitals, Leicester
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
9500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emma P Beeston
- Phone Number: 0116 204 4738
- Email: emma.beeston@uhl-tr.nhs.uk
Study Contact Backup
- Name: Tara Maitland
- Phone Number: 0116 204 4737
- Email: tara.maitland@uhl-tr.nhs.uk
Study Locations
-
-
-
Leicester, United Kingdom
- Recruiting
- University Hospitals Leicester
-
Contact:
- Emma P Beeston
-
-
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 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Participants recruited from secondary care, inpatient and outpatient departments.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
|
Physiological Measurements Patient reported questionnaire Blood sampling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
20 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To improve prediction of responses to different treatments, using blood proteins or chemicals and a patient's genetic makeup
Time Frame: 20 Years
|
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.
|
20 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nilesh J Samani, Professor, NIHR Leicester Biomedical Research Centre
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)
June 17, 2010
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (Actual)
May 14, 2020
Study Record Updates
Last Update Posted (Actual)
June 11, 2026
Last Update Submitted That Met QC Criteria
June 10, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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