EPIC-ACS: Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients

• Sponsor: University Hospital, Essen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03787797
• Collaborator: (none)
• Enrollment: 653
• Location: 1
• Anticipated Duration (Months): 39.8
• Patients Per Site Per Month: 16.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Diagnostic Test: Echocardiography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 653 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Epicardial Adipose Tissue Thickness PredIcts Obstructive Coronary Artery Disease in Acute Coronary Syndrome Patients
• Actual Study Start Date: Dec 6, 2018
• Actual Primary Completion Date: Dec 14, 2020
• Anticipated Study Completion Date: Mar 30, 2022

Outcome Measures

Primary Outcome Measures

1. Coronary revascularization [within 90 days after initial presentation]

   Number of Participants with need for coronary revascularization therapy

Secondary Outcome Measures

1. Invasive coronary angiography [within 90 days after initial presentation]

   Number of Participants undergoing invasive coronary angiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Essen	Essen	NRW	Germany	4

Sponsors and Collaborators

• University Hospital, Essen

Investigators

• Principal Investigator: Amir A Mahabadi, MD, University Hospital, Essen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amir Abbas Mahabadi, Principal Investigator, University Hospital, Essen
• ClinicalTrials.gov Identifier: NCT03787797
• Other Study ID Numbers: 18-8402-BO
• First Posted: Dec 26, 2018
• Last Update Posted: Oct 8, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amir Abbas Mahabadi, Principal Investigator, University Hospital, Essen: Epicardial adipose tissue; Chest pain; Echocardiography; Coronary artery disease
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Oct 8, 2021