Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorUniversity Hospitals, Leicester
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Participants recruited from secondary care, inpatient and outpatient departments.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Observation
Other interventionPhysiological Measurements Patient reported questionnaire Blood sampling
Treatment groups
9,500 Participants
are divided into 1 treatment groupGroup A: 11 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
20 YearsSecondary 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.
Time frame
20 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospitals, Leicester
Lead sponsor
University of Leicester
Collaborator
Source ClinicalTrials.gov