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

Sponsor
IRCCS Policlinico S. Donato (Other)
Overall Status
Recruiting
CT.gov ID
NCT05081362
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
11.6
Anticipated Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Oct 6, 2022
Anticipated Study Completion Date :
Oct 6, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Arterial pressure measured in mmHg [6 months]

    Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.

  2. Heart rate measured in bpm [6 months]

    Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.

  3. Respiratory frequency [6 months]

    Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age over 18

  • spontaneous sinus rhythm

  • signed informed consent

Exclusion Criteria:
  • no spontaneous sinus rhythm

  • pregnancy

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1IRCCS Policlinico San DonatoSan Donato MilaneseMilanoItaly20097

Sponsors and Collaborators

  • IRCCS Policlinico S. Donato

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marco Ranucci, Head of cardiovascular anesthesiology and intensive care, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT05081362
Other Study ID Numbers:
  • COVIDans
First Posted:
Oct 18, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021