Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease (COVIDans)

January 23, 2023 updated by: Marco Ranucci, IRCCS Policlinico S. Donato
The goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18
  • spontaneous sinus rhythm
  • signed informed consent

Exclusion Criteria:

  • no spontaneous sinus rhythm
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: COVID-severe
patient recovered from severe COVID desease
Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position
Other: COVID-moderate
patient recovered from moderate COVID desease
Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position
Other: COVID-mild
patient recovered from mild COVID desease
Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity during ten minutes in rest and ten minutes in orthostatic position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial pressure measured in mmHg
Time Frame: 6 months
Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.
6 months
Heart rate measured in bpm
Time Frame: 6 months
Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.
6 months
Respiratory frequency
Time Frame: 6 months
Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2021

Primary Completion (Actual)

November 9, 2022

Study Completion (Actual)

November 9, 2022

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVIDans

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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