Left Ventricular ThrombusNCT04871126
Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for LVT in ANT-MI With Left Ventricular Dysfunction
An observational study of Left Ventricular Thrombus and Acute Anterior Myocardial Infarction, run by Henan Provincial People's Hospital.
Trial summary
To investigate the predictive value of inflammatory indexes and CHA2DS2-VASc score for anterior myocardial infarction (ANT-MI) with left ventricular thrombus(LVT) (LVT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Ventricular Thrombus, Acute Anterior Myocardial Infarction, Left Ventricular Dysfunction
- What is being tested?
- inflammatory indexes and CHA2DS2-VASc score
- How many people
- 371 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included a total of 371 patients with anterior myocardial infarction (ANT-MI) treated with emergency prior percutaneous coronary intervention (pPCI) in our hospital betweenfrom January 2014 andto January 2021. Patients were eligible for enrollmentenrolment if they had a reduced left ventricularLV ejection fraction (LVEF) ( ≤40%). and if detailed data on demographic and clinical characteristics were documented. Exclusion criteria were end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity (Figure 1). Based on the study criteria, 123 patients were excluded from the study; thus, 248 patients were included in the analysis.
Who may be able to join
- acute anterior myocardial infarction with left ventricular dysfunction
Who cannot join
- end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity
About this study
Official title: Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for Left Ventricular Thrombus in Acute Anterior Myocardial Infarction With Left Ventricular Dysfunction
To investigate the predictive value of inflammatory indexes and CHA2DS2-VASc score for anterior myocardial infarction (ANT-MI) with left ventricular thrombus(LVT) (LVT).
Read the detailed description
The clinical data were collected from 371consecutive patients with ANT-MI in our hospital from January 2014 to January 2021.As a result,totally 62 patients with LVT were selected as the experimental group and 186 patients with non-LVT as the control group .The observation indexes included baseline data, coronary angiography, disease course, laboratory examination and auxiliary examination.Patients with severe organic disease and having previous history of left ventricular aneurysm( LVA) and LVT were excluded.Data was analyzed by software SPSS 22.0 for statistical analysis,and the logistic regression model was established.A P<0.05 was considered statistically significant, and the risk factors of LVT formation were retrospectively analyzed.
- Conditions
- Left Ventricular Thrombus, Acute Anterior Myocardial Infarction, Left Ventricular Dysfunction
- Being tested
- inflammatory indexes and CHA2DS2-VASc score
- Keywords
- left ventricular thrombus;anterior myocardial infarction, Risk factors
- Medical subject headings
- Anterior Wall Myocardial Infarction, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammatory indexes and CHA2DS2-VASc scoreOther
inflammatory indexes and CHA2DS2-VASc score
| Study group | Role | What they receive |
|---|---|---|
| LVT group | left ventricular thrombus in acute anterior myocardial infarction patients with left ventricular dysfunction Receives: Other: inflammatory indexes and CHA2DS2-VASc score | |
| non-LVTgroup | acute anterior myocardial infarction patients with left ventricular dysfunction while without LVT Receives: Other: inflammatory indexes and CHA2DS2-VASc score |
What is being measured
The primary outcome is the main question the study is designed to answer.
the predictive of the inflammatory indexes and CHA2DS2-VASc score in LVT
the logistic regression model was established between the indexes and LVT
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Jan 2014
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular ThrombusStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871126
- Sponsor's protocol ID
- CHA2DS2-VASc score
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for Left Ventricular Thrombus in Acute Anterior Myocardial Infarction With Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT04871126
- Acronym / sponsor ID
- CHA2DS2-VASc score
- Conditions
- Left Ventricular Thrombus, Acute Anterior Myocardial Infarction, Left Ventricular Dysfunction
- Keywords
- left ventricular thrombus;anterior myocardial infarction, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 4 May 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.
To investigate the predictive value of inflammatory indexes and CHA2DS2-VASc score for anterior myocardial infarction (ANT-MI) with left ventricular thrombus(LVT) (LVT).
Detailed description
The clinical data were collected from 371consecutive patients with ANT-MI in our hospital from January 2014 to January 2021.As a result,totally 62 patients with LVT were selected as the experimental group and 186 patients with non-LVT as the control group .The observation indexes included baseline data, coronary angiography, disease course, laboratory examination and auxiliary examination.Patients with severe organic disease and having previous history of left ventricular aneurysm( LVA) and LVT were excluded.Data was analyzed by software SPSS 22.0 for statistical analysis,and the logistic regression model was established.A P<0.05 was considered statistically significant, and the risk factors of LVT formation were retrospectively analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVT group | – | Other: inflammatory indexes and CHA2DS2-VASc scoreleft ventricular thrombus in acute anterior myocardial infarction patients with left ventricular dysfunction |
| non-LVTgroup | – | Other: inflammatory indexes and CHA2DS2-VASc scoreacute anterior myocardial infarction patients with left ventricular dysfunction while without LVT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included a total of 371 patients with anterior myocardial infarction (ANT-MI) treated with emergency prior percutaneous coronary intervention (pPCI) in our hospital betweenfrom January 2014 andto January 2021. Patients were eligible for enrollmentenrolment if they had a reduced left ventricularLV ejection fraction (LVEF) ( ≤40%). and if detailed data on demographic and clinical characteristics were documented. Exclusion criteria were end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity (Figure 1). Based on the study criteria, 123 patients were excluded from the study; thus, 248 patients were included in the analysis.
Key inclusion criteria (1 listed)
- acute anterior myocardial infarction with left ventricular dysfunction
Key exclusion criteria (1 listed)
- end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity
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 |
|---|---|---|
| inflammatory indexes and CHA2DS2-VASc scoreinflammatory indexes and CHA2DS2-VASc score | Other | LVT group, non-LVTgroup |
Primary outcome
the predictive of the inflammatory indexes and CHA2DS2-VASc score in LVT
Time frame: Day 1
the logistic regression model was established between the indexes and LVT
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 May 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Thrombus and Acute Anterior Myocardial Infarction, run by Henan Provincial People's Hospital.
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 1 inclusion and 1 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
the predictive of the inflammatory indexes and CHA2DS2-VASc score in LVT (time frame: Day 1). 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 4 May 2021.