Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)

Recruiting

• Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor
• Interventions: Other: Observation

• Registration Number: NCT04388943
• Lead Sponsor: University Hospitals, Leicester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-17
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Study First Posted: 2020-05-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 9500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Observation	-

Primary Outcome Measures

Name	Time	Method
To improve understanding of disease mechanisms in cardiovascular disease	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.

Secondary Outcome Measures

Name	Time	Method
To improve prediction of responses to different treatments, using blood proteins or chemicals and a patient's genetic makeup	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.

Trial Locations

Locations (1)

University Hospitals Leicester; 🇬🇧 Leicester, United Kingdom