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临床试验/NCT05238402
NCT05238402已完成不适用

The Impact of Statin Therapy in the Covid-19 Patients With Very High Cardiovascular Risk

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 707 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
707
试验地点
1
主要终点
Mortality

研究概览

简要总结

In the retrospective case series, consecutive COVID-19 patients admitted from June 1 to December 31, 2020, were analyzed. A 1:1 matched cohort was created by propensity score-matched analysis. Demographic data, laboratory findings, comorbidities, treatments, and in-hospital outcomes were collected and compared between COVID-19 patients with and without statin use.

详细描述

Methods Study population The study is retrospective single-center review of all patients admitted to Antalya Training and Research Center, tested positive for SARS-CoV-2 reverse transcriptase-polymerase chain reaction testing of nasopharyngeal or oropharyngeal specimens from January 1, 2020, to December 31, 2020., and informed consent was waived. The study conformed to the principles of the Declaration of Helsinki and was approved by the ethics committee of Antalya training and research center (2021-059).

Baseline demographic, clinical, and laboratory variables were retrieved from the electronic medical record system. Patients were classified according to the HeartScore high-risk countries risk chart. Patients identified in the very high cardiovascular risk group were included in the analysis. The study population was divided into two groups: patients who received a statin vs. those who did not receive a statin before the hospitalization. The primary outcome was in-hospital mortality during the follow-up period.

Statistical analysis Summary statistics were presented as percentages for categorical variables and medians with interquartile ranges or means with standard deviations for continuous variables. Differences in demographic, clinical characteristics and outpatient medications stratified by statin use were examined using the two-sided independent t-test and chi-squared test, as appropriate.

To minimize the influence of confounding by indication, propensity-score matching was used to balance the clinical characteristics of the two groups. Matching was performed using a 1:1 matching protocol without replacement (greedy-matching algorithm), with a caliper width equal to 0.02 of the standard deviation of the propensity score's logit. The following variables were used for adjustment: age, sex, history of atrial fibrillation, cancer, chronic kidney disease, chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, diabetes mellitus, hypertension, smoking, and corticosteroid treatment. Descriptive analyses were performed for all baseline variables in the overall cohort and the propensity-matched cohort.

To identify potential predictors of mortality, we initially performed a univariate logistic regression in the overall cohort. Covariables with p < 0.20 were selected for entry into the multivariable model, and covariables with p > 0.05 were removed from the final model. Similarly, both univariable and multivariable logistic regression was performed in the propensity-score matched cohort. All analyses were performed with the SAS software version 9.4 (SAS Institute, Inc., Cary, NC, USA).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID 19 diagnosis
  • Very high cardiovascular risk

排除标准

  • < 40 years old

研究组 & 干预措施

on statins

patients who received a statin

干预措施: Statin (Drug)

not on statins

patients who not received a statin

干预措施: Statin (Drug)

结局指标

主要结局

Mortality

时间窗: up to 1 month

In-hospital mortality

次要结局

未报告次要终点

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Deniz Demirci

Principal Investigator

Antalya Training and Research Hospital

研究点 (1)

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