Cardiac and Non Cardiac Thoracal DisorderACS-StrainNCT02357641
Acute Coronary Disease (ACS)- Strain
An observational study of Cardiac and Non Cardiac Thoracal Disorder, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Examination of probable distinction between cardiac or non- cardiac thoracal disorder via echocardiographic myocardial strain analysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac and Non Cardiac Thoracal Disorder
- What is being tested?
- retrospective echographic myocardial strain analysis refering to acute coronary syndrome
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Jan 2015
- 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: 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.
Who may be able to join
- thoracal cardiac or non cardiac disorder
- signed informed consent
Who cannot join
- glomerular filtration rate (GFR) < 60 ml/min
- angina pectoris
- acute myocardial infarction within 3 months prior inclusion
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52057
About this study
Official title: 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
Read the 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.
- Being tested
- retrospective echographic myocardial strain analysis refering to acute coronary syndrome
- Keywords
- acute coronary disease, echographic strain analysis, cut off
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective echographic myocardial strain analysis refering to acute coronary syndromeOther
retrospective evaluation for cut off value of circumferential and radial echographic strain parameters corresponding to acute coronary disease
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: retrospective echographic myocardial strain analysis refering to acute coronary syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of cut off value of circumferential and radial myocardial echographic strain data corresponding to acute coronary disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
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 Cardiac and Non Cardiac Thoracal DisorderStudies 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg Schroeder, MD, Principal investigator, University Hospital Aachen, Clinic of Cardiology, Angiology, Pneumology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357641
- Sponsor's protocol ID
- CTC-A 13-089
- Acronym
- ACS-Strain
- Status last verified
- Feb 2015
- First submitted
- 26 Jan 2015
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26349786
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Myocardial Deformation in Patients With Acute Coronary Disease
- ClinicalTrials.gov ID
- NCT02357641
- Acronym / sponsor ID
- ACS-Strain / CTC-A 13-089
- Keywords
- acute coronary disease, echographic strain analysis, cut off
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with thoracal disorder | – | Other: retrospective echographic myocardial strain analysis refering to acute coronary syndrome300 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- thoracal cardiac or non cardiac disorder
- signed informed consent
Key exclusion criteria (4 listed)
- glomerular filtration rate (GFR) < 60 ml/min
- angina pectoris
- acute myocardial infarction within 3 months prior inclusion
- pregnancy
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 |
|---|---|---|
| retrospective echographic myocardial strain analysis refering to acute coronary syndromeretrospective evaluation for cut off value of circumferential and radial echographic strain parameters corresponding to acute coronary disease | Other | Patients with thoracal disorder |
Primary outcome
Determination of cut off value of circumferential and radial myocardial echographic strain data corresponding to acute coronary disease
Time frame: 1 year
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 6 Feb 2015.
- Derived from this study: PubMed 26349786Schroeder 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.
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.
Joerg Schroeder, MD principal investigator
University Hospital Aachen, Clinic of Cardiology, Angiology, Pneumology and Intensive Care Medicine
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 Cardiac and Non Cardiac Thoracal Disorder, run by RWTH Aachen University 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 2 inclusion and 4 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 6 Feb 2015. 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?
Determination of cut off value of circumferential and radial myocardial echographic strain data corresponding to acute coronary disease (time frame: 1 year). 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 NCT02357641, 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 6 Feb 2015.