NCT03787797

Brief Summary

Epicardial adipose tissue (EAT) is a visceral adipose tissue that surrounds the heart and the coronary arteries. It is metabolically active, secreting pro- and anti-inflammatory mediators and cytokines. With increasing EAT volume, inflammatory activity increasing, which suggests that EAT may locally influence atherosclerosis development in the coronary artery tree. The amount of EAT is associated with cardiovascular disease risk factors as well as presence and progression of subclinical atherosclerosis. Likewise, EAT volume is increased in patient with prevalent and incident coronary artery disease manifestation. In the setting of acute coronary syndrome, EAT was found to be associated with the TIMI risk score and Syntax II score. While CT imaging of the heart is the gold standard for EAT quantification, transthoracic echocardiography allows for a quick and reliable assessment of EAT thickness, as has been used in research studies and may qualify for routine EAT assessment in clinical routine.However, currently data on how quantification of EAT in clinical routine may impact patient management is lacking. We aim to investigate, whether quantification of EAT thickness via transthoracic echocardiography enables improved risk stratification in patients presenting with acute chest pain to the emergency department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
657

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 6, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

December 21, 2018

Last Update Submit

November 2, 2022

Conditions

Keywords

Epicardial adipose tissueChest painEchocardiographyCoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Coronary revascularization

    Number of Participants with need for coronary revascularization therapy

    within 90 days after initial presentation

Secondary Outcomes (1)

  • Invasive coronary angiography

    within 90 days after initial presentation

Interventions

EchocardiographyDIAGNOSTIC_TEST

Assessment of epicardial adipose tissue thickness

Eligibility Criteria

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

Inclusion of patients without known coronary artery disease undergoing workup for suspected acute coronary syndrome at the emergency department of the University Hospital Essen.

You may qualify if:

  • admission to the emergency department of the University Hospital Essen with acute chest pain suggestive of an acute coronary syndrome

You may not qualify if:

  • Known obstructive coronary artery disease prior to presentation, prior revascularization therapy, unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 4, Germany

Location

Related Publications (1)

  • Roggel A, Jehn S, Dykun I, Balcer B, Al-Rashid F, Totzeck M, Risse J, Kill C, Rassaf T, Mahabadi A. Regional wall motion abnormalities on focused transthoracic echocardiography in patients presenting with acute chest pain: a predefined post hoc analysis of the prospective single-centre observational EPIC-ACS study. BMJ Open. 2024 Sep 10;14(9):e085677. doi: 10.1136/bmjopen-2024-085677.

MeSH Terms

Conditions

Acute Coronary SyndromeChest PainCoronary Artery Disease

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Amir A Mahabadi, MD

    University Hospital, Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2018

First Posted

December 26, 2018

Study Start

December 6, 2018

Primary Completion

December 14, 2020

Study Completion

August 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

IPD will be made available upon request.

Locations