Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease (COVIDans)
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- age over 18
- spontaneous sinus rhythm
- signed informed consent
Exclusion Criteria:
- no spontaneous sinus rhythm
- pregnancy
Sites / Locations
- IRCCS Policlinico San Donato
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
COVID-severe
COVID-moderate
COVID-mild
Arm Description
patient recovered from severe COVID desease
patient recovered from moderate COVID desease
patient recovered from mild COVID desease
Outcomes
Primary Outcome Measures
Arterial pressure measured in mmHg
Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.
Heart rate measured in bpm
Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.
Respiratory frequency
Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.
Secondary Outcome Measures
Full Information
NCT ID
NCT05081362
First Posted
October 7, 2021
Last Updated
January 23, 2023
Sponsor
IRCCS Policlinico S. Donato
1. Study Identification
Unique Protocol Identification Number
NCT05081362
Brief Title
Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
Acronym
COVIDans
Official Title
Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
November 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID-severe
Arm Type
Other
Arm Description
patient recovered from severe COVID desease
Arm Title
COVID-moderate
Arm Type
Other
Arm Description
patient recovered from moderate COVID desease
Arm Title
COVID-mild
Arm Type
Other
Arm Description
patient recovered from mild COVID desease
Intervention Type
Other
Intervention Name(s)
Non invasive cardiovascular monitoring with CNAP device of arterial pressure, ECG and respiratory activity
Intervention Description
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
Primary Outcome Measure Information:
Title
Arterial pressure measured in mmHg
Description
Continuous measurement of the arterial pressure for 10 minutes in rest and 10 minutes in orthostatic position.
Time Frame
6 months
Title
Heart rate measured in bpm
Description
Continuous measurement of heart rate for 10 minutes in rest and 10 minutes in orthostatic position.
Time Frame
6 months
Title
Respiratory frequency
Description
Continuous measurement of respiratory frequency for 10 minutes in rest and 10 minutes in orthostatic position.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age over 18
spontaneous sinus rhythm
signed informed consent
Exclusion Criteria:
no spontaneous sinus rhythm
pregnancy
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
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