NCT04388943

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2010Mar 2027

Study Start

First participant enrolled

June 17, 2010

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

16.8 years

First QC Date

May 13, 2020

Last Update Submit

June 10, 2026

Conditions

Outcome Measures

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.

    20 Years

Secondary Outcomes (1)

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

    20 Years

Study Arms (1)

1

Other: Observation

Interventions

Physiological Measurements Patient reported questionnaire Blood sampling

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants recruited from secondary care, inpatient and outpatient departments.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leicester

Leicester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Nilesh J Samani, Professor

    NIHR Leicester Biomedical Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 14, 2020

Study Start

June 17, 2010

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations