Noninvasive Myocardial WorkNCT05874752
Myocardial Function Assessment in Patients With Coronary Artery Disease Using Noninvasive Myocardial Work
An observational study of Noninvasive Myocardial Work and Coronary Artery Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Noninvasive pressure-strain loop (PSL) derived myocardial work (MW) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Noninvasive Myocardial Work, Coronary Artery Disease
- What is being tested?
- Transthoracic echocardiography
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Jun 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were hospitalized for coronary angiography with angina or equivalent symptoms.
Inclusion Criteria: Patients who were hospitalized for coronary angiography with angina or equivalent symptoms.
-
Exclusion Criteria: Acute coronary syndrome, left main stem coronary disease, left ventricular ejection fraction (LVEF) below 55%, observed resting regional wall motion abnormalities (RWMAs), non-sinus rhythm, intraventricular block, previous cardiac surgery, severe valvular heart disease, hypertrophic cardiomyopathy, myocarditis, pericardial diseases, pulmonary hypertension, and poor image quality.
-
Trial locations and contacts
1 site in 1 country.
About this study
Noninvasive pressure-strain loop (PSL) derived myocardial work (MW) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. The aim of this study was to assess left ventricular (LV) myocardial function in symptomatic patients with coronary artery disease using the promising method.
Methods: Transthoracic echocardiography was performed on patients with angina or equivalent symptoms before coronary angiography. Images were stored and imported into the software for further offline analysis of PSL-based MW. MW analysis were carried out on each patient for global and regional myocardial function assessment.
- Being tested
- Transthoracic echocardiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
noninvasive myocardial work
| Study group | Role | What they receive |
|---|---|---|
| nonsignificant coronary artery stenosis group | Exclusion criteria: ≥70% proximal luminal stenosis in at least one major coronary vessel based on coronary angiography Receives: Diagnostic Test: Transthoracic echocardiography | |
| significant coronary artery stenosis group | Defined as ≥70% proximal luminal stenosis in at least one major coronary vessel based on coronary angiography Receives: Diagnostic Test: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial function
noninvasive myocardial work indices
Measured: baseline (before coronary angiography)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Oct 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive Myocardial WorkStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingmei Liu, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874752
- Sponsor's protocol ID
- SYSKY-2022-029-01
- Status last verified
- Apr 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Function Assessment in Patients With Coronary Artery Disease Using Noninvasive Myocardial Work
- ClinicalTrials.gov ID
- NCT05874752
- Acronym / sponsor ID
- SYSKY-2022-029-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 25 May 2023 (actual)
- 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.
Noninvasive pressure-strain loop (PSL) derived myocardial work (MW) are more sensitive than conventional echocardiographic parameters in quantitative assessment of early myocardial dysfunction. The aim of this study was to assess left ventricular (LV) myocardial function in symptomatic patients with coronary artery disease using the promising method.
Methods: Transthoracic echocardiography was performed on patients with angina or equivalent symptoms before coronary angiography. Images were stored and imported into the software for further offline analysis of PSL-based MW. MW analysis were carried out on each patient for global and regional myocardial function assessment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nonsignificant coronary artery stenosis group | – | Diagnostic Test: Transthoracic echocardiographyExclusion criteria: ≥70% proximal luminal stenosis in at least one major coronary vessel based on coronary angiography |
| significant coronary artery stenosis group | – | Diagnostic Test: Transthoracic echocardiographyDefined as ≥70% proximal luminal stenosis in at least one major coronary vessel based on coronary angiography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were hospitalized for coronary angiography with angina or equivalent symptoms.
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 |
|---|---|---|
| Transthoracic echocardiographynoninvasive myocardial work | Diagnostic test | nonsignificant coronary artery stenosis group, significant coronary artery stenosis group |
Primary outcome
myocardial function
Time frame: baseline (before coronary angiography)
noninvasive myocardial work indices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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.
Yingmei Liu principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Noninvasive Myocardial Work and Coronary Artery Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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 China. 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?
Results are not available in the source record.
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?
myocardial function (time frame: baseline (before coronary angiography)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2023.