Effect of COVID-19 on Endothelial Function

NCT05500560 | Completed

• 1 other identifier: 16/02-02-2022
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 disease (coronavirus disease 2019) primarily affects the respiratory system, using the angiotensin-converting enzyme 2 receptor. However, there is increasing evidence that COVID-19 can also affect the heart (myocardial injury, myocarditis, arrhythmias) and the vascular system, effects that may worsen the clinical outcome of patients. The aim of this study is to assess the effect of COVID-19 on the patients' endothelial function, during the acute phase of the disease (inpatient), shortly after recovery (2 months) and in the mid-term (6 months). Evaluation of endothelial function will be performed non-invasively by the method of Peripheral Arterial Tonometry (PAT) using the EndoPAT2000 system (Itamar Medical, Israel). This is a prospective, case-controlled, single-center clinical observational study. The study will include adult patients who developed COVID-19 disease for whom admission for hospitalization was required, while the control group will consist of healthy volunteers matched for age, gender and cardiovascular risk factors. Patients enrolled in the study will undergo the following visits:

• Visit 1: Hospitalization
• Visit 2: 2 months after discharge
• Visit 3: 6 months after discharge
• Visit 4: 1 year after discharge Patients will be subjected to measurement of the reactive hyperemia index with the EndoPAT2000 system in Visits 1, 2 and 3. The aim of the study is to compare the endothelial function between the two groups (COVID-19 vs. Controls).

Conditions

COVID-19; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Natural logarithm of reactive hyperemia index (Ln-RHI)

  Endothelial dysfunction is defined as LnRHI≤0.51

  2 months after discharge

Secondary Outcomes (11)

• Area under the Curve (AUC) of the Reactive Hyperemia index (RHI) measurements during hospitalization, at 2 months after discharge and at 6 months after discharge.

  At 6 months after discharge

• Natural logarithm of reactive hyperemia index (Ln-RHI)

  During hospitalization (up to day 10)

• Reactive Hyperemia Index (RHI)

  At 6 months after discharge

• Rate of endothelial dysfunction (LnRHI≤0.51)

  During hospitalization (up to day 10)

• Rate of endothelial dysfunction (LnRHI≤0.51)

  At 2 months after discharge

Study Arms (2)

COVID-19

Patients admitted to our hospital due to COVID-19

Controls

Healthy volunteers matched for age, sex and cardiovascular risk factors.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include adult patients who developed COVID-19 disease for which admission for hospitalization was required, while the control group will be healthy matched volunteers for age, gender and cardiovascular risk factors.

You may qualify if:

• Age \>18 years
• Documented SARS-COV-2 infection with PCR test
• Need for hospitalization in a COVID clinic
• Informed written consent

You may not qualify if:

• Inability to cooperate for peripheral arterial tonometry
• Hemodynamic instability
• High probability of non-compliance with the procedures of the study
• Reduced life expectancy \<1 year
• Established atherosclerotic cardiovascular disease
• Pregnancy, postpartum
• Alcoholism

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

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

• Athanasios Moulias, MD, PhD

  General University Hospital of Patras

  PRINCIPAL INVESTIGATOR

• Periklis Davlouros, MD, PhD

  General University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 15, 2022
• Study Start: March 2, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)