Clinical trial NCT04388943: Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
Official title: Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: University of Leicester
First posted: 2020-05-14
Enrollment: 9500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from secondary care, inpatient and outpatient departments.

Brief 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. 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: 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

Primary outcomes:
measure: To improve understanding of disease mechanisms in cardiovascular disease
timeFrame: 20 Years
Secondary outcomes:
measure: To improve prediction of responses to different treatments, using blood proteins or chemicals and a patient's genetic makeup
timeFrame: 20 Years
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
Study officials:
affiliation: NIHR Leicester Biomedical Research Centre
name: Nilesh J Samani, Professor
role: PRINCIPAL_INVESTIGATOR
References: