- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04871126
Predictive Value of Inflammatory Indexes and CHA2DS2-VASc Score for LVT in ANT-MI With Left Ventricular Dysfunction
April 28, 2021 updated by: Henan Provincial People's Hospital
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
371
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
acute anterior myocardial infarction with left ventricular dysfunction
Exclusion Criteria:
end-stage organic disease, thrombotic hematological disorders, previous anticoagulant use, and poor echogenicity
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
LVT group
left ventricular thrombus in acute anterior myocardial infarction patients with left ventricular dysfunction
|
inflammatory indexes and CHA2DS2-VASc score
|
non-LVTgroup
acute anterior myocardial infarction patients with left ventricular dysfunction while without LVT
|
inflammatory indexes and CHA2DS2-VASc score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 1, 2014
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
January 1, 2021
Study Registration Dates
First Submitted
April 25, 2021
First Submitted That Met QC Criteria
April 28, 2021
First Posted (Actual)
May 4, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHA2DS2-VASc score
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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