COVID-19 Testing in Patients With Vascular Disorders

• ClinicalTrials.gov Identifier: NCT04838093
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Mohammad M. Kasiri, Medical University of Vienna

Study Description

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.

Condition or disease	Intervention/treatment
Covid19	Diagnostic Test: PCR

Study Design

• Study Type: Observational
• Actual Enrollment: 2243 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID-19 Testing in Patients With Vascular Disorders - a Prospective Cohort Study at a Tertiary Care Hospital
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: December 1, 2020
• Actual Study Completion Date: January 1, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patient cohort: all patients with vascular disorders consecutively admitted at our tertiary care hospital from March 16 to December 07, 2020	Diagnostic Test: PCR; 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: 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; 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.
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; 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.

Outcome Measures

Primary Outcome Measures :

1. prevalence of SARS-CoV-2 infection [ Time Frame: March 16 to December 07, 2020 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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).

Criteria

Inclusion Criteria:

All inpatient admissions

Exclusion Criteria:

Outpatient admissions

Contacts and Locations

Locations

Austria

Medical University of Vienna

Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

• Study Chair: Wolf W Eilenberg, MD. PhD.; Wolf.eilenberg@meduniwien.ac.at

More Information

• Responsible Party: Mohammad M. Kasiri, Resident doctor in general surgery, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT04838093
• Other Study ID Numbers: 2049/2020
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: All study data will be made available upon request.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Vascular Diseases; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cardiovascular Diseases