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临床试验/NCT05715879
NCT05715879已完成不适用

The Long-term Effects of the Covid-19 Infection on Cardiac Symptoms, Should We Have a Realistic Concern?

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 879 人开始时间: 2020年10月1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
879
试验地点
1
主要终点
dyspnea

研究概览

简要总结

From the registry of professor Kojuri clinic , those with Covid-19 infection were selected and was contacted and asked about the cardiovascular symptoms, 1 year after the covid infection

详细描述

This retrospective cohort study was conducted between October 2020 to May 2021. The study population was patients referring to Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email: kojurij@yahoo.com, webpage: http://kojuriclinic.com). A database of patients' information is available, including underlying diseases, signs and symptoms, medications, laboratory tests, electrocardiography, and echocardiography. The data is documented by expert cardiologists on every patient's visit.

The inclusion criteria were having a history of COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago. The exclusion criteria were having a history of documented COVID-19 infection, which occurred less than a year ago, and having a probable history of COVID-19 not confirmed by PCR or HRCT.

Patients' information before COVID-19 infection was extracted from the database, including baseline demographic data, COVID-19 vaccination history, hypertension (HTN), dyslipidemia (or hyperlipidemia (HLP)), diabetes mellitus (DM), smoking, CVD, and prescribed medications. Patients with incomplete data before COVID-19 or with outdated data were excluded.

We contacted the enrolled patients to get informed about their symptoms, such as dyspnea at rest, dyspnea on exertion (DOE), orthopnea, paroxysmal nocturnal dyspnea (PND) 21, chest pain (CP) 22, fatigue 23, and palpitations 24. Patients were asked to rate their dyspnea at rest from 0 to 10, according to the 10-category ratio. A score of zero means no breathing discomfort, and ten indicates the most severe dyspnea. A score between 1 to 4 was considered mild, 5 to 6 moderate, and 7 to 10 severe. We also used functional class 1 to 4 to assess their dyspnea. Functional class 1 means no limitations in daily activities, functional class 2 means mild exertional dyspnea, functional class 3 indicates moderate dyspnea with daily activities, and functional class 4 figures dyspnea at rest 25. Chest pain was defined, based on the American heart association 2021, as "noncardiac," "possible cardiac," and "cardiac" 22.

A history of major adverse cardiovascular events (MACE) during a year follow-up of COVID-19 infection and admission due to COVID-19 were also reported. MACE is defined as myocardial infarction (MI), admission due to heart failure (HF), stroke, cardiac death, and revascularization procedures, including coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) 26.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 78 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago

排除标准

  • COVID-19 infection, which occurred less than a year ago,
  • probable history of COVID-19 not confirmed by PCR or HRCT

结局指标

主要结局

dyspnea

时间窗: 1 year

Abnormal shortness of breath with lower activities or at rest

chest pain

时间窗: 1 year

cheat pain mimicking angina

MACE

时间窗: 1 year

major adverse cardiac events, myocardial infarction, admission, death or nead for revascularization

次要结局

  • fatigue(1 year)

研究者

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

Javad Kojuri

professor

Shiraz University of Medical Sciences

研究点 (1)

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