COVID-19 Testing in Patients With Vascular Disorders

NCT04838093 | Completed

• 1 other identifier: 2049/2020
• Study Type: observational
• Target: 2,243
• Locations: 1 country
• Sites: 1

Brief Summary

Background: To investigate the prevalence of SARS-CoV-2 infection in hospitalized patients with vascular disorders after implementing institutional and governmental safety measures. Materials and Methods: Vascular patients (VPs) admitted to our tertiary care hospital were routinely tested for SARS-CoV-2 infection on a two days basis between March and December, 2020. The prevalence of SARS-CoV-2 was compared between VPs and two independent Austrian populations (April and November 2020) tested by the Austrian Ministry of Science. The results were also compared to a cohort of health care personnel (HCP) working in close proximity to the study patients, tested weekly, between March and December, 2020. RT-PCR and antigen test were used to detect SARS-CoV-2.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• prevalence of SARS-CoV-2 infection

  The primary endpoint of the present study was to determine the prevalence of SARS-CoV-2 infection in patients with vascular disease after the implementation of institutional and governmental safety measures and compared it to SARS-CoV-2 infections among the general population in Austria.

  March 16 to December 07, 2020

Study Arms (3)

Patient cohort:

all patients with vascular disorders consecutively admitted at our tertiary care hospital from March 16 to December 07, 2020

Diagnostic Test: PCR

Control cohort:

data of two nationwide PCR-based studies conducted in a representative random sample, from April 1-6, and November 12-14, 2020, collected by the Austrian Ministry of Science and the Austrian Red Cross to estimate the spread of SARS-CoV-2 infection among the non-hospitalized Austrian population.

Diagnostic Test: PCR

HCP cohort:

HCP worker data, including nurses, nurse technicians, physicians, surgical personal, physical therapists, nurse practitioners, environmental service workers, administrative staff, and dietitians, working in close proximity to admitted patients at our tertiary care hospital from March 16 to December 07, 2020.

Diagnostic Test: PCR

Interventions

PCR DIAGNOSTIC_TEST

Nasal or pharyngeal respiratory swabs were routinely taken of each patient admitted at our departments and repeated regularly at 48 h intervals during the inpatient stay. In the HCP cohort testing for SARS-CoV-2 RNA was performed, on a weekly basis, at the Department of Laboratory Medicine, Medical University of Vienna, Austria, using real-time polymerase chain reaction (RT-PCR). Comparability of the results of all test methods used was confirmed by participation in international quality control ring trials.

Control cohort:; HCP cohort:; Patient cohort:

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We investigated clinical data from all patients presenting at the hospital with vascular disorders, including peripheral artery disease (PAD), cardiac disorders (CD), aortic aneurysm (AA), extracranial artery disorders (EAD) and venous disorders (VD).

You may qualify if:

• All inpatient admissions

You may not qualify if:

• Outpatient admissions

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wolf W Eilenberg, MD. PhD.

  Wolf.eilenberg@meduniwien.ac.at

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor in general surgery

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)