Covid-19 Infection and Long-term Cardiovascular Symptoms

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT05715879
Collaborator
(none)
879
1
7
126.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: covid infection
  • Biological: admission to hispital

Detailed Description

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 Patients with incomplete data before COVID-19 or with outdated data were excluded.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.

HTN is defined as clinic SBP ≥140 mm Hg or DBP ≥90 mm Hg in repeated assessment 27. DM is diagnosed based on the American diabetes association (ADA) 2020 guidelines 28. Dyslipidemia is defined as abnormalities in TG, LDL, or HDL cholesterol. A TG level of more than 150 mg/dL is considered abnormal. HDL less than 40 mg/dL, LDL more than 100mg/dL, or is defined as dyslipidemia 29. Current smokers are defined as those who have smoked ≥100 cigarettes and smoked during the 30 days preceding the study. Former smokers have stopped smoking more than 30 days before the research 30.

Statistical analysis was performed using SPSS for Windows ver. 26 (IBM Corp., Armonk, NY, USA). We described continuous variables by mean ±standard deviation. Categorical variables were described by frequency and percentage. We used repeated measure ANOVA and paired-sample t-test for normal distribution variables and Wilcoxon signed-rank test for repeated categorical variables. Pearson's chi-squared test and Kruskal-Wallis test are applied to categorical data. We controlled the effects of confounding factors by using generalized linear models and repeating analyses by different subgroups. Statistical significance was indicated when P<0.05.

All patients were informed about the details of this research and provided their informed consent. Patients who declined to participate in the study were excluded

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
879 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Long-term Effects of the Covid-19 Infection on Cardiac Symptoms, Should We Have a Realistic Concern?
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
diseased

covid infection patients

Diagnostic Test: covid infection
patients with covid infection which was proved with positive test
Other Names:
  • covid 19 infection
  • Biological: admission to hispital
    patients with sever covid disease, who was admitted in hospital

    Outcome Measures

    Primary Outcome Measures

    1. dyspnea [1 year]

      Abnormal shortness of breath with lower activities or at rest

    2. chest pain [1 year]

      cheat pain mimicking angina

    3. MACE [1 year]

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

    Secondary Outcome Measures

    1. fatigue [1 year]

      feeling weakness with less than ordinary activities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    43 Years to 71 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago
    Exclusion Criteria:
    • COVID-19 infection, which occurred less than a year ago,

    • probable history of COVID-19 not confirmed by PCR or HRCT

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiology Ward Shiraz University of Medical Sciences Shiraz Fars Iran, Islamic Republic of 51318

    Sponsors and Collaborators

    • Shiraz University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Javad Kojuri, professor, Shiraz University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05715879
    Other Study ID Numbers:
    • IR.SUMS.MED.REC.1401.465
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Javad Kojuri, professor, Shiraz University of Medical Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2023