Acute Coronary Disease (ACS)- Strain (ACS-Strain)

February 3, 2015 updated by: RWTH Aachen University

Analysis of Myocardial Deformation in Patients With Acute Coronary Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine Westphalia
      • Aachen, North Rhine Westphalia, Germany, 52057
        • Department of Cardiology, RWTH Aachen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with thoracal disorder

300 patients with thoracal disorder, cardiac or non- cardiac, are enrolled prospectively to undergo routinely examinations such as clinical and hemodynamic chemistry as well as echocardiography for strain analysis refering to myocardial deformation.

Especially analysis of strain data (circumferential and radial), regional and global left and right ventricular wall movement data and diastolic parameters will be analysed retrospectively to investigate a probable cut off value corresponding to acute coronary disease or non cardiac disorder (Intervention: retrospective echographic myocardial strain analysis refering to acute coronary syndrome).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of cut off value of circumferential and radial myocardial echographic strain data corresponding to acute coronary disease
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Joerg Schroeder, MD, University Hospital Aachen, Clinic of Cardiology, Angiology, Pneumology and Intensive Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-A 13-089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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