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临床试验/NCT05770336
NCT05770336已完成不适用

STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.

研究概览

简要总结

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

详细描述

In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms is common. Studies of the acute phase of Covid-19 infection have shown a significant prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the presence of structural changes in the pericardium and myocardium several months after the acute phase.

The aim of the project is to identify the prevalence and characteristics of long-term cardiovascular changes in Covid-19 infection.

The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on cardiovascular changes during the acute phase and shortly after the acute phase. The study design is retrospective observational. The study plans to enroll 240 patients hospitalized during the acute phase of COVID-19 infection. Patients will be collected at three separate centers. Enrolled patients will undergo a baseline evaluation by history, physical examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

If alterations in left ventricular or right ventricular systolic function are found, as per the standard clinical approach, a cardiac MRI examination will be evaluated.

Identification of patients with cardiac changes is of paramount importance as they may benefit from early initiation of cardioprotective therapy and may need different follow-up strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with previous hospitalization for Covid-19 infection confirmed by pharyngeal molecular swab
  • Adult patients between 18 and 90 years of age
  • Signature of informed consent

排除标准

  • Patient with poor echocardiographic acoustic window impairing the performance of the examination
  • Patients with atrial fibrillation
  • Patients with ischemic or nonischemic heart disease with known decreased left ventricular systolic function

结局指标

主要结局

Identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage.

时间窗: 9 months

The main purpose of this study is to identify the long-term myocardial damage and compare it with the prevalence and extent of acute myocardial damage. The anatomical and functional substrates of cardiovascular manifestations will be analyzed by basic and advanced echocardiographic technologies

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agricola Eustachio

PI

IRCCS San Raffaele

研究点 (1)

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