Clinical trial NCT02357641: Acute Coronary Disease (ACS)- Strain
Official title: Analysis of Myocardial Deformation in Patients With Acute Coronary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac and Non Cardiac Thoracal Disorder
Keywords: acute coronary disease, echographic strain analysis, cut off
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 300 patients with vague thoracal disorder -cardiac or non cardiac- are enrolled prospectively to undergo routinely echography as well as routine examinations such as anamnetic, hemodynamic examinations and laboratory. The distinction between non cardiac disorder or acute coronary disease (ACS) is offen difficult so that time- consuming and expensive ischemic diagnostics or coronary artery angiography will follow. To prevent these time consuming or expensive diagnostics retrospectively a cut off value will be determined of systolic, diastolic and additionally of circumferential and radial echographic strain data analysis corresponding to acute coronary disease.

Brief summary: Examination of probable distinction between cardiac or non- cardiac thoracal disorder via echocardiographic myocardial strain analysis

Detailed description: Patients with cardiac disorder have to undergo time- consuming and expensive examinations such as laboratory of cardiac biomarkers or ischemic diagnostic. To save time and money in this observational registry the probable distinction between cardiac and non- cardiac disorder in patients with vague thoracal disorder and the probability for coronary artery disease (determined via Grace Score) is examined via echographic myocardial strain analysis in 300 patients retrospectively to establish a cut off value corresponding to acute coronary disease also to prevent coronary angiography. Therefore patients undergo echography routinely with consecutive evaluation of systolic, diastolic and strain analysis to elevate exact statements with reference to deformation of the myocard and its velocity. Several study have shown that these strain parameters (circumferential and radial strain) enable vitality and ischemic diagnosis and therefore could be eligible for this purpose.

Eligibility criteria: Inclusion Criteria:

* thoracal cardiac or non cardiac disorder
* signed informed consent

Exclusion Criteria:

* glomerular filtration rate (GFR) \< 60 ml/min
* angina pectoris
* acute myocardial infarction within 3 months prior inclusion
* pregnancy

Primary outcomes:
measure: Determination of cut off value of circumferential and radial myocardial echographic strain data corresponding to acute coronary disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Cardiology, RWTH Aachen University Hospital
state: North Rhine Westphalia
Study officials:
affiliation: University Hospital Aachen, Clinic of Cardiology, Angiology, Pneumology and Intensive Care Medicine
name: Joerg Schroeder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schroeder J, Hamada S, Grundlinger N, Rubeau T, Altiok E, Ulbrich K, Keszei A, Marx N, Becker M. Myocardial deformation by strain echocardiography identifies patients with acute coronary syndrome and non-diagnostic ECG presenting in a chest pain unit: a prospective study of diagnostic accuracy. Clin Res Cardiol. 2016 Mar;105(3):248-56. doi: 10.1007/s00392-015-0916-2. Epub 2015 Sep 8.