ST-Segment Elevated Myocardial InfarctionNCT05107102
Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With STEMI
An observational study of ST-Segment Elevated Myocardial Infarction, run by RenJi Hospital at 1 site in China.
Trial summary
The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-Segment Elevated Myocardial Infarction
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2019to 30 Aug 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with anterior STEMI who underwent primary PCI <12 hours after symptom onset were consecutive enrolled in our center.
Who may be able to join
- Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
- Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.
Who cannot join
- significant valvular disease;
- cardiomyopathy; l
- left bundle branch block;
- atrial fibrillation;
- previous myocardial infarction (MI);
- history of cardiac surgery;
- pacemaker implantation.
Trial locations and contacts
1 site in 1 country.
China1 site
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200125
About this study
Official title: Value of Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Intervention
The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.
- Keywords
- ST-segment elevated myocardial infarction, myocardial work, left ventricular remodeling
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with LVR(left ventricular remodeling) | Not described | |
| patients without LVR(left ventricular remodeling) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta-work efficiency by echocardiography
A novel tool for non-invasive myocardial work(MW) assessment has been introduced to evaluate myocardial performance.MW was calculated as a function of time through a combination of LV global longitudinal strain(GLS) data and an estimated LV pressure curves. Work efficiency (WE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.The values of culprit regional WE was expressed as WE-LAD.The values of non-culprit regional WE was expressed as WE-nonLAD.The absolute differences of the WE was calculated as the values of non-culprit regional WE minus the values of culprit regional WE, and noted as delta-WE.
Measured: 24-72 hours after PCI
Secondary outcomes (6)
Global work index by echocardiography
Global work index (GWI) is classified as total work within the area of the LV pressure-strain loop calculated from mitral valve closure to mitral valve opening.
Measured: 24-72 hours, 3-month after PCI
Global constructive work by echocardiography
Global constructive work (GCW) was defined as work contributing to LV ejection performed during shortening in systole and work performed during lengthening in isovolumic relaxation.
Measured: 24-72 hours, 3-month after PCI
Global work efficiency by echocardiography
Global work efficiency (GWE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.
Measured: 24-72 hours, 3-month after PCI
Work index-LAD
Work index in left anterior descending(LAD) territory.
Measured: 24-72 hours, 3-month after PCI
Constructive work-LAD
constructive work in left anterior descending(LAD) territory.
Measured: 24-72 hours, 3-month after PCI
Work efficiency-LAD
Work efficiency in left anterior descending(LAD) territory.
Measured: 24-72 hours, 3-month after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 Sep 2019
- Primary completion24 May 2021
- Study completion30 Aug 2021
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 ST-Segment Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Song Ding, MD,PHD, Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107102
- Sponsor's protocol ID
- STEMI-myocardial work
- Status last verified
- Oct 2021
- First submitted
- 24 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang W, Zhao H, Wan F, Shen XD, Ding S, Pu J. Inhomogeneous Distribution of Regional Myocardial Work Efficiency Predicts Early Left Ventricular Remodeling After Acute Anterior Myocardial Infarction Treated With Primary Percutaneous Intervention. Front Cardiovasc Med. 2022 Jul 27;9:922567. doi: 10.3389/fcvm.2022.922567. eCollection 2022.
PubMed 35966524
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Myocardial Work for Prediction of Left Ventricular Remodeling in Patients With ST-Elevation Myocardial Infarction Treated by Primary Percutaneous Intervention
- ClinicalTrials.gov ID
- NCT05107102
- Acronym / sponsor ID
- STEMI-myocardial work
- Keywords
- ST-segment elevated myocardial infarction, myocardial work, left ventricular remodeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 4 Nov 2021 (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.
The study intends to investigate the alteration of regional myocardial work in patients with acute anterior myocardial infarction underwent primary percutaneous coronary intervention (PCI), and compare the distribution of regional myocardial work in patients with/without early remodeling at acute phase and 3-month follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with LVR(left ventricular remodeling) | – | – |
| patients without LVR(left ventricular remodeling) | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with anterior STEMI who underwent primary PCI <12 hours after symptom onset were consecutive enrolled in our center.
Key inclusion criteria (2 listed)
- Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
- Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.
Key exclusion criteria (7 listed)
- significant valvular disease;
- cardiomyopathy; l
- left bundle branch block;
- atrial fibrillation;
- previous myocardial infarction (MI);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delta-work efficiency by echocardiography
Time frame: 24-72 hours after PCI
A novel tool for non-invasive myocardial work(MW) assessment has been introduced to evaluate myocardial performance.MW was calculated as a function of time through a combination of LV global longitudinal strain(GLS) data and an estimated LV pressure curves. Work efficiency (WE) was calculated from the ratio of the constructive work to the sum of constructive and wasted work, expressed as a percentage.The values of culprit regional WE was expressed as WE-LAD.The values of non-culprit regional WE was expressed as WE-nonLAD.The absolute differences of the WE was calculated as the values of non-culprit regional WE minus the values of culprit regional WE, and noted as delta-WE.
6 secondary outcomes
Global work index by echocardiography
Time frame: 24-72 hours, 3-month after PCI
Global constructive work by echocardiography
Time frame: 24-72 hours, 3-month after PCI
Global work efficiency by echocardiography
Time frame: 24-72 hours, 3-month after PCI
Work index-LAD
Time frame: 24-72 hours, 3-month after PCI
Constructive work-LAD
Time frame: 24-72 hours, 3-month after PCI
Work efficiency-LAD
Time frame: 24-72 hours, 3-month after PCI
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 4 Nov 2021.
- Derived from this study: PubMed 35966524Wang W, Zhao H, Wan F, Shen XD, Ding S, Pu J. Inhomogeneous Distribution of Regional Myocardial Work Efficiency Predicts Early Left Ventricular Remodeling After Acute Anterior Myocardial Infarction Treated With Primary Percutaneous Intervention. Front Cardiovasc Med. 2022 Jul 27;9:922567. doi: 10.3389/fcvm.2022.922567. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Song Ding, MD,PHD principal investigator
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong 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 ST-Segment Elevated Myocardial Infarction, run by RenJi Hospital 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?
The sponsor lists 2 inclusion and 7 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 4 Nov 2021. 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?
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?
Delta-work efficiency by echocardiography (time frame: 24-72 hours after PCI). 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 NCT05107102, 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 4 Nov 2021.