NCT03674255

Brief Summary

EVAREST will identify and validate novel blood and imaging biomarkers of potential value for consistent and accurate interpretation of stress echocardiography. During phase one, blood samples will be collected to assess the impact of cardiac stress on levels of circulating biomarkers and examine whether the measurement of these biomarkers can provide additional prognostic information. Phases one, two and three will also determine whether novel imaging biomarkers can be identified in the echocardiograms that can be used for objective interpretation of the stress echocardiograms. EVAREST will recruit up to 8000 patients (First 500 during phase one, an additional 500 during phase two and an additional 7000 during phase three) from multiple hospitals across United Kingdom, who have been referred for a stress echocardiogram as part of their investigations into ischaemic heart disease. Phase four of the study will continue into a clinical study cohort phase to capture information from all patients referred for a stress echocardiogram in the UK, regardless of the reason for investigation.This registry phase will run for 2 years, recruiting up to 15000 participants.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
23,000

participants targeted

Target at P75+ for all trials

Timeline
89mo left

Started Mar 2015

Longer than P75 for all trials

Status
enrolling by invitation

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 Progress60%
Mar 2015Sep 2033

Study Start

First participant enrolled

March 1, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
12.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Expected
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6 years

First QC Date

September 4, 2018

Last Update Submit

April 28, 2026

Conditions

Coronary Artery DiseaseIschaemic Heart DiseaseAngina Pectoris

Keywords

Stress EchocardiographyBlood BiomarkersExtracellular VesiclesImaging BiomarkersMachine LearningArtificial IntelligenceIschaemic Heart DiseaseCoronary Artery DiseaseAngina Pectoris

Outcome Measures

Primary Outcomes (2)

  • Assessment of Prognostically Significant CAD

    Patients will be followed up one year after their stress echocardiogram to determine whether they have prognostically significant CAD. This is defined as \>70% stenosis assessed by angiography (either via invasive coronary angiography or CT coronary angiography), an FFR\< 0.85 or the intention to revascularize (either via PCI or CABG). Any tests that occur in a ten year period after the stress echocardiogram will also be recorded.

    Data will be collected for ten years after the patient undergoes the stress echocardiogram.

  • Examination of Medical Records

    Medical records will also be examined to check for any acute coronary syndromes within the year following the stress echocardiogram. Participants will also be contacted by telephone to capture any out-of-hospital events. Further follow-up data will be captured up to 10 years after the patient's initial stress echocardiogram.

    Data will be collected for ten years after the patient undergoes the stress echocardiogram.

Secondary Outcomes (4)

  • Quantification of Extracellular Vesicles (obtained from blood samples) by Flow Cytometry

    Blood samples will be obtained before and after the stress echocardiogram. Analysis will be complete one year from the date of the stress echocardiogram

  • Assessment of Time to Diagnosis

    Data will be collected for ten years after the patient undergoes the stress echocardiogram.

  • Analysis of Potential Cost Savings Through the Use of Novel Biomarkers By the Reduction in Unnecessary Procedures

    Data will be collected for ten years after the patient undergoes the stress echocardiogram.

  • Investigation into the use of stress echocardiography as a clinical procedure in the UK.

    Data will be collected for ten years after the patient undergoes the stress echocardiogram.

Study Arms (4)

1

Participants in group 1 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained, in addition to venous blood samples obtained from the cannula inserted as part of the standard clinical procedure. These blood samples will be collected before and after the stress echocardiogram. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data.

2

Participants in group 2 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data.

3

Participants in group 3 will be recruited at their stress echocardiogram appointment. Anonymised versions of the stress echocardiograms will be obtained. These participants will be followed up by telephone call after one year to determine whether they had any additional cardiac tests or events outside of their hospital trust. Medical records relating to the participant will be reviewed annually for up to 10 years to identify if the patient has been admitted and obtain health outcome data.

4

Participants in group 4 will be recruited at their stress echocardiogram appointment, regardless of the type of investigation. A simplified data set and an anonymised version of the stress echocardiography report will be collected as a part of this registry phase. Participants will be followed up over a 10-year period.

Eligibility Criteria

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

For phases 1 - 3, patients will be recruited when attending hospital for a stress echocardiogram to investigate the presence of ischaemic heart disease. For phase 4, patients attending hospital for a stress echocardiogram, for any investigation, will be recruited.

You may qualify if:

  • Patients must be undergoing a stress echocardiogram to investigate the presence of ischaemic heart disease (groups 1-3).
  • Patients must be able to provide informed consent.
  • Patients must be aged over 18 years of age.

You may not qualify if:

  • Patients undergoing stress echocardiography to assess valvular function.
  • Patients who are unwilling or unable to provide informed consent.
  • Patients aged under 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Alsharqi M, Upton R, Mumith A, Leeson P. Artificial intelligence: a new clinical support tool for stress echocardiography. Expert Rev Med Devices. 2018 Aug;15(8):513-515. doi: 10.1080/17434440.2018.1497482. Epub 2018 Jul 19. No abstract available.

    PMID: 29992841BACKGROUND

  • Augustine D, Ayers LV, Lima E, Newton L, Lewandowski AJ, Davis EF, Ferry B, Leeson P. Dynamic release and clearance of circulating microparticles during cardiac stress. Circ Res. 2014 Jan 3;114(1):109-13. doi: 10.1161/CIRCRESAHA.114.301904. Epub 2013 Oct 18.

    PMID: 24141170BACKGROUND

  • Ayers L, Nieuwland R, Kohler M, Kraenkel N, Ferry B, Leeson P. Dynamic microvesicle release and clearance within the cardiovascular system: triggers and mechanisms. Clin Sci (Lond). 2015 Dec;129(11):915-31. doi: 10.1042/CS20140623.

    PMID: 26359252BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained from participants recruited into group 1. Samples will be obtained before and after the stress echocardiogram.

MeSH Terms

Conditions

Coronary Artery DiseaseAngina Pectoris

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Leeson

    Cardiovascular Clinical Research Facility, University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 17, 2018

Study Start

March 1, 2015

Primary Completion

March 1, 2021

Study Completion (Estimated)

September 1, 2033

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share