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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388943
• Other study ID #: 14022
• Status: Recruiting
• Start date: June 17, 2010
• Est. completion date: March 31, 2027

Study information

• Verified date: November 2023
• Source: University Hospitals, Leicester
• Contact: Emma P Beeston
• Phone: 0116 204 4738
• Email: emma.beeston[@]uhl-tr.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9500
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

Other:
• Observation
Physiological Measurements Patient reported questionnaire Blood sampling

Locations

Country	Name	City	State
United Kingdom	University Hospitals Leicester	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals, Leicester	University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 Years
Secondary	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.	20 Years