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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05798208
Other study ID # IR.SUMS.MED.REC.1401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2020
Est. completion date February 20, 2023

Study information

Verified date April 2023
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this single center , retrospective study, 5355 covid patient were selected from 2020 to 2022, with recorded blood pressure before covid and recording after covid. Blood pressure before and after covid were compared, by pair T test.


Description:

design and participants This single-center retrospective cohort study was conducted at an outpatient cardiology clinic in Shiraz, Iran, between February 15, 2020, and December 28, 2022. We evaluated patients with a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by RNA reverse-transcriptase polymerase-chain-reaction assays from nasopharyngeal or oropharyngeal swab specimens according to World Health Organization guidelines (12). Two physicians (PA, MY) reviewed the patients' electronic medical records, including demographics, comorbidities, vital signs, treatments, and outcomes. Ambiguities were resolved by a third author (MM). The current study included all COVID-19 patients who had at least one documented blood pressure measurement in the three months preceding infection and one documented measurement one to three months following recovery. The following patients were excluded: those under 18, with hospital admission due to COVID-19, who received corticosteroid therapy, those with a history of systemic inflammatory disease, kidney or liver, immunocompromised patients, and those who switched their antihypertensive regimen during the study. Finally, 5,355 eligible patients were investigated . The primary outcome was to assess BP variation following infection (particularly a prolonged rise in BP) among non-hospitalized COVID-19 patients. The secondary outcome was to identify the predictor factors of BP variation. The present study was approved by the Ethics Committee of Shiraz University of Medical Sciences under code IR.SUMS.MED.REC.1401.465 , and the need for informed consent was waived due to the study's retrospective nature and the absence of patient identifiers in the presented data.


Recruitment information / eligibility

Status Completed
Enrollment 5355
Est. completion date February 20, 2023
Est. primary completion date December 28, 2022
Accepts healthy volunteers
Gender All
Age group 39 Years to 71 Years
Eligibility Inclusion Criteria: - All COVID-19 patients who had at least one documented blood pressure measurement in the three months preceding infection and one documented measurement one to three months following recovery Exclusion Criteria: - Age under 18 - Hospital admission due to COVID-19 - Corticosteroid therapy, - History of systemic inflammatory disease - kidney disease - liver disease - Immunocompromised patients

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
blood pressure measurement
Taking blood pressure with automated arm sphygmomanometer and pressure higher than 140/90 was considered abnormal

Locations

Country Name City State
Iran, Islamic Republic of Cardiology Ward Shiraz University of Medical Sciences Shiraz Fars
Iran, Islamic Republic of Education Developmen Center Shiraz Fars
Iran, Islamic Republic of Professor kojuri cardiology clinic Shiraz Outside Of The US

Sponsors (1)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of blood pressure any change in blood pressure level before and after covid infection 2 years
Secondary predictors of changes in blood pressure history of any risk factor for cardiac disease, age, sex, 2 years
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