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Echocardiography: Value and Accuracy at REst and STress (EVAREST)

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ClinicalTrials.gov Identifier: NCT03674255
Recruitment Status : Enrolling by invitation
First Posted : September 17, 2018
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Oxford University Hospitals NHS Trust
Royal United Hospital Bath NHS Trust
Tameside Hospital NHS Foundation Trust
Royal Berkshire NHS Foundation Trust
East Lancashire Hospitals NHS Trust
Bradford Teaching Hospitals NHS Foundation Trust
Calderdale and Huddersfield NHS Foundation Trust
Great Western Hospital NHS Foundation Trust
Mid Essex Hospital NHS Trust
Buckinghamshire Healthcare NHS Trust
Wrightington, Wigan and Leigh NHS Foundation Trust
Chelsea and Westminster Hospital NHS Foundation Trust
Milton Keynes University Hospital NHS Foundation Trust
University Hospitals Bristol and Weston NHS Foundation Trust
North Middlesex University Hospital
Northumbria Healthcare NHS Foundation Trust
London North West Healthcare NHS Trust
St George's University Hospitals NHS Foundation Trust
Ultromics Ltd
National Institute for Health Research, United Kingdom
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Poole Hospital NHS Foundation Trust
Blackpool Teaching Hospitals NHS Foundation Trust
Mid Yorkshire Hospitals NHS Trust
Northampton General Hospital NHS Trust
North West Anglia NHS Foundation Trust
Yeovil District Hospital NHS Foundation Trust
East Suffolk and North Essex NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Hampshire Hospitals NHS Foundation Trust
Lantheus Medical Imaging
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease
Coronary Artery Disease Ischaemic Heart Disease Angina Pectoris

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Study Type : Observational
Estimated Enrollment : 23000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Imaging and Blood Biomarkers to Improve the Diagnostic Accuracy of Cardiac Assessment by Stress Echocardiogram
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : January 2032

Group/Cohort
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.



Primary Outcome Measures :
  1. Assessment of Prognostically Significant CAD [ Time Frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram. ]
    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.

  2. Examination of Medical Records [ Time Frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram. ]
    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.


Secondary Outcome Measures :
  1. Quantification of Extracellular Vesicles (obtained from blood samples) by Flow Cytometry [ Time Frame: Blood samples will be obtained before and after the stress echocardiogram. Analysis will be complete one year from the date of the stress echocardiogram ]
    The concentration of a comprehensive panel of cell-derived extracellular vesicles (such as erythrocyte, endothelial and platelet-derived extracellular vesicles) will be measured via flow cytometry in both the pre-stress and post-stress blood samples to assess the effect of cardiac stress on their concentration. The concentrations will also be compared between the patients with and without prognostically significant coronary artery disease to determine whether the concentration of extracellular vesicles is affected by coronary artery disease.

  2. Assessment of Time to Diagnosis [ Time Frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram. ]
    We will assess whether the use of novel imaging and blood biomarkers can reduce the time to diagnosis of prognostically significant CAD.

  3. Analysis of Potential Cost Savings Through the Use of Novel Biomarkers By the Reduction in Unnecessary Procedures [ Time Frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram. ]
    Health economic assessment will be carried out to determine whether the inclusion of imaging and blood biomarkers in the diagnostic process can ultimately lead to cost reductions through the reduction in unnecessary procedures and treatments.

  4. Investigation into the use of stress echocardiography as a clinical procedure in the UK. [ Time Frame: Data will be collected for ten years after the patient undergoes the stress echocardiogram. ]
    Analysis of the number and type of stress echocardiograms performed across UK NHS sites as well as demographic information on the patients referred for stress echocardiography and accuracy of stress echocardiography, using follow-up data.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674255


Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Royal United Hospital Bath NHS Trust
Tameside Hospital NHS Foundation Trust
Royal Berkshire NHS Foundation Trust
East Lancashire Hospitals NHS Trust
Bradford Teaching Hospitals NHS Foundation Trust
Calderdale and Huddersfield NHS Foundation Trust
Great Western Hospital NHS Foundation Trust
Mid Essex Hospital NHS Trust
Buckinghamshire Healthcare NHS Trust
Wrightington, Wigan and Leigh NHS Foundation Trust
Chelsea and Westminster Hospital NHS Foundation Trust
Milton Keynes University Hospital NHS Foundation Trust
University Hospitals Bristol and Weston NHS Foundation Trust
North Middlesex University Hospital
Northumbria Healthcare NHS Foundation Trust
London North West Healthcare NHS Trust
St George's University Hospitals NHS Foundation Trust
Ultromics Ltd
National Institute for Health Research, United Kingdom
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Poole Hospital NHS Foundation Trust
Blackpool Teaching Hospitals NHS Foundation Trust
Mid Yorkshire Hospitals NHS Trust
Northampton General Hospital NHS Trust
North West Anglia NHS Foundation Trust
Yeovil District Hospital NHS Foundation Trust
East Suffolk and North Essex NHS Foundation Trust
Nottingham University Hospitals NHS Trust
Hampshire Hospitals NHS Foundation Trust
Lantheus Medical Imaging
Investigators
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Principal Investigator: Paul Leeson Cardiovascular Clinical Research Facility, University of Oxford
Publications:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03674255    
Other Study ID Numbers: 18100
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Stress Echocardiography
Blood Biomarkers
Extracellular Vesicles
Imaging Biomarkers
Machine Learning
Artificial Intelligence
Ischaemic Heart Disease
Coronary Artery Disease
Angina Pectoris
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Arteriosclerosis
Chest Pain
Pain
Neurologic Manifestations