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)

Enrollment

Location

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 Disease	Intervention/Treatment	Phase
COVID-19	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

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

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

Outcome Measures

Primary Outcome Measures

Arterial pressure measured in mmHg [6 months]
Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.
Heart rate measured in bpm [6 months]
Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.
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:

Inclusion Criteria:

age over 18
spontaneous sinus rhythm
signed informed consent

Exclusion Criteria:

no spontaneous sinus rhythm
pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Donato	San Donato Milanese	Milano	Italy	20097

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:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 19, 2021