OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS)
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- STATUS
- Recruiting
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- participants needed
- 60
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- sponsor
- Xuzhou Third People's Hospital
Summary
This is a prospective study of a new generation of drug-eluting
Description
This study is a prospective, randomized controlled clinical trial, which will adopt the
central randomized method based on computer system. When a patient signs the informed consent
form and meets the inclusion criteria of the trial, and there is
The trial was carried out according to the following procedures: (1) signing informed
consent; (2) case screening; (3) case selection; (4) The baseline
The task of data management and statistical analysis of this experiment will be undertaken by
clinical research center of cardiovascular medicine of the third people's Hospital of Xuzhou
City, and the statistical professionals will participate in the whole process of research
design, implementation, data management and analysis and summary of
The case report form (
During the clinical trial, the investigator of the hospital where the implementer is located
and the investigator of the third people's Hospital of Xuzhou City will visit the research
center regularly to ensure that all contents of the research scheme are strictly observed,
and the original data are checked to ensure that the content of
Definition of adverse event: refers to any medical event, unexpected disease or
Severity of adverse events: mild:
Response measures for adverse events: all adverse events occurred during the study must be recorded in the adverse event table truthfully. The researchers should give targeted treatment and follow-up until the symptoms disappear or stable.
Serious adverse events: serious adverse events refer to the events that need
Statistical analysis method:
Descriptive analysis: composition ratio is used to describe counting data, mean, standard deviation, maximum value and minimum value are used to describe measuring data, mean, standard deviation, maximum value, minimum value, median, 25th and 75th quantiles are used to describe non normal distribution data.
Baseline demographic analysis: when the theoretical frequency in the four grid table is less
than 5, Fisher's exact probability method is used; group
Efficacy analysis: paired t-test was used for comparison in normal distribution measurement
group, and Wilcoxon rank sum
Safety
All statistical analysis will be performed at the bilateral 0.05 significance level. Sas9.13 statistical software is used for statistical analysis.
Details
Condition |
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---|---|
Age | 18years - 80years |
Treatment |
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Clinical Study Identifier | NCT04375319 |
Sponsor | Xuzhou Third People's Hospital |
Last Modified on | 19 February 2024 |
How to participate?
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2 study centers available
Xuzhou Third People's Hospital
China
Peixian Guotai hospital
China
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Xuzhou Third People's Hospital
China
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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