Acute Coronary Disease (ACS)- Strain

Cardiac and Non Cardiac Thoracal Disorder Clinical Trial

— ACS-Strain  

Official title:

Analysis of Myocardial Deformation in Patients With Acute Coronary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357641
• Other study ID #: CTC-A 13-089
• Status: Completed
• Phase: N/A
• First received: January 26, 2015
• Last updated: February 3, 2015
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac and Non Cardiac Thoracal Disorder
• Coronary Artery Disease
• Coronary Disease

Intervention

Other:
• retrospective echographic myocardial strain analysis refering to acute coronary syndrome
retrospective evaluation for cut off value of circumferential and radial echographic strain parameters corresponding to acute coronary disease

Locations

Country	Name	City	State
Germany	Department of Cardiology, RWTH Aachen University Hospital	Aachen	North Rhine Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of cut off value of circumferential and radial myocardial echographic strain data corresponding to acute coronary disease		1 year	Yes