Acute Coronary SyndromeEPIC-ACSNCT03787797
Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients
An observational study of Acute Coronary Syndrome, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Echocardiography
- How many people
- 657 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2018to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- admission to the emergency department of the University Hospital Essen with acute chest pain suggestive of an acute coronary syndrome
Who cannot join
- Known obstructive coronary artery disease prior to presentation, prior revascularization therapy, unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Echocardiography
- Keywords
- Epicardial adipose tissue, Chest pain, Echocardiography, Coronary artery disease
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Assessment of epicardial adipose tissue thickness
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary revascularization
Number of Participants with need for coronary revascularization therapy
Measured: within 90 days after initial presentation
Secondary outcomes (1)
Invasive coronary angiography
Number of Participants undergoing invasive coronary angiography
Measured: within 90 days after initial presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start6 Dec 2018
- Primary completion14 Dec 2020
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 657 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Abbas Mahabadi, University Hospital, Essen
- Investigators
- Amir A Mahabadi, MD, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787797
- Sponsor's protocol ID
- 18-8402-BO
- Acronym
- EPIC-ACS
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available upon request.
Publications
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.
PubMed 39260858
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients
- ClinicalTrials.gov ID
- NCT03787797
- Acronym / sponsor ID
- EPIC-ACS / 18-8402-BO
- Conditions
- Acute Coronary Syndrome
- Keywords
- Epicardial adipose tissue, Chest pain, Echocardiography, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 657 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- admission to the emergency department of the University Hospital Essen with acute chest pain suggestive of an acute coronary syndrome
Key exclusion criteria (1 listed)
- Known obstructive coronary artery disease prior to presentation, prior revascularization therapy, unwillingness to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyAssessment of epicardial adipose tissue thickness | Diagnostic test | – |
Primary outcome
Coronary revascularization
Time frame: within 90 days after initial presentation
Number of Participants with need for coronary revascularization therapy
1 secondary outcome
Invasive coronary angiography
Time frame: within 90 days after initial presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 39260858Roggel 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.
- Individual participant dataSharing planned: Yes. IPD will be made available upon request.
Related trials for Acute Coronary Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir A Mahabadi, MD principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary revascularization (time frame: within 90 days after initial presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.