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Clinical and Imaging Biomarkers Associated With Plasma ad Cellular Determinants of Cardiovascular Disease at the Time of COVID 19 (CARDIOCOVID)

Primary Purpose

Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sample blood
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Diseases focused on measuring Covid 19, Pneumonia

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Women and men between the ages of 45 and 90; Patients diagnosed with cardiovascular disease; Patients with diabetes; Patients with dyslipidemia; Patients with hypertension, myocardial infarction (pre-existing or acute STEMI or NSTEMI event) chronic stable angina, peripheral vascular disease, stroke or TIA Exclusion Criteria: Inflammatory diseases and/or infections (except for the IMA-COVID-19 group); Tumors, immunological and/or hematological disorders; Ejection fraction less than 40%; Treatments with anti-inflammatory drugs, with the exception of low-dose aspirin, and antibiotic therapies up to 1 month before enrolment.

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Partecipants with cardiovascular disease

Partecip with cardiovascular disease and affected by COVID-19

Arm Description

The research program will examine imaging and clinical biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of COVID-19 infection. This will make it possible to re-evaluate the cardiovascular risk profile of subjects with cardiovascular diseases.

In this arm we investigate the immune dysregulation that may play a role in the evolution of cardiovascular disease characteristics of chronic and convalescent COVID-19 participants, in this field we will perform detailed clinical cardiological and immunological phenotyping on enrolled patients.

Outcomes

Primary Outcome Measures

Assess cardiovascular risk
The primary objective is to examine clinical and imaging biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of COVID-19 infection, to reevaluate the cardiovascular risk profile of individuals with cardiovascular disease

Secondary Outcome Measures

The prevalence of cardiovascular risk factors in chronic COVID 19 partecipants.
Study the prevalence of cardiovascular risk factors by collecting partecipants information and analyzing data using conventional statistical analysis and machine learning techniques to develop multivariable models and identify those at greatest risk and investigation of immune dysregulation may play a role in the evolution of CV disease characteristics of chronic and convalescent COVID-19 patrtecipants, in this field we will perform detailed clinical cardiological and immunological phenotyping on enrolled patients.

Full Information

First Posted
February 23, 2023
Last Updated
February 24, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05745753
Brief Title
Clinical and Imaging Biomarkers Associated With Plasma ad Cellular Determinants of Cardiovascular Disease at the Time of COVID 19
Acronym
CARDIOCOVID
Official Title
Clinical and Imaging Biomarkers Associated With Plasma ad Cellular Determinants of Cardiovascular Disease at the Time of COVID 19 (CardioCovid)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 16, 2021 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute and chronic cardiovascular complications of pneumonia are common and result from various mechanisms, including relative ischemia, systemic inflammation, and pathogen-mediated injury. However, there is only limited published data regarding on cardiovascular desease (CV) submissions in the wake of viral outbreaks. Data collected during the COVID-19 pandemic highlighted a number of possible determinants of adverse outcome in these patients, particularly with reference to cardio-respiratory complications.
Detailed Description
The risk of death increases substantially after age 60, in men and in overweight patients. Cardiac involvement, characterized by elevation of cardiac Troponin I and brain-like natriuretic peptide, is frequent in COVID-19 patients and is associated with a worse prognosis. Finally, right ventricular (RV) dilatation and dysfunction is the most common echocardiographic abnormality in patients with COVID-19, at least in part due to a substantial incidence of pulmonary thromboembolism (PTE). Cardiac abnormalities in COVID-19 patients include changes in heart rate and cardiac autonomic modulation, as well as systemic activation of inflammatory processes, with endothelial damage and involvement of the CV and respiratory systems. The research program will examine imaging and clinical biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of COVID-19 infection. This will make it possible to re-evaluate the cardiovascular risk profile of subjects with cardiovascular diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
Covid 19, Pneumonia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Creation within the data platform of the Cardiology Network of a database of studies containing relevant information on patients with cardiovascular diseases with and without COVID 19; Study the prevalence of cardiovascular risk factors by collecting patient information and analyzing data using conventional statistical analysis and machine learning techniques to develop multivariable models and identify those at greatest risk.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partecipants with cardiovascular disease
Arm Type
Experimental
Arm Description
The research program will examine imaging and clinical biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of COVID-19 infection. This will make it possible to re-evaluate the cardiovascular risk profile of subjects with cardiovascular diseases.
Arm Title
Partecip with cardiovascular disease and affected by COVID-19
Arm Type
Experimental
Arm Description
In this arm we investigate the immune dysregulation that may play a role in the evolution of cardiovascular disease characteristics of chronic and convalescent COVID-19 participants, in this field we will perform detailed clinical cardiological and immunological phenotyping on enrolled patients.
Intervention Type
Other
Intervention Name(s)
sample blood
Other Intervention Name(s)
clinical history and peripheral blood sampling
Intervention Description
At the time of enrolment, peripheral blood sampling is expected at the outpatient clinic of the experimental center and the study of the patient's clinical history.
Primary Outcome Measure Information:
Title
Assess cardiovascular risk
Description
The primary objective is to examine clinical and imaging biomarkers associated with plasma and cellular determinants of cardiovascular disease, taking into account the potential effects of COVID-19 infection, to reevaluate the cardiovascular risk profile of individuals with cardiovascular disease
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The prevalence of cardiovascular risk factors in chronic COVID 19 partecipants.
Description
Study the prevalence of cardiovascular risk factors by collecting partecipants information and analyzing data using conventional statistical analysis and machine learning techniques to develop multivariable models and identify those at greatest risk and investigation of immune dysregulation may play a role in the evolution of CV disease characteristics of chronic and convalescent COVID-19 patrtecipants, in this field we will perform detailed clinical cardiological and immunological phenotyping on enrolled patients.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women and men between the ages of 45 and 90; Patients diagnosed with cardiovascular disease; Patients with diabetes; Patients with dyslipidemia; Patients with hypertension, myocardial infarction (pre-existing or acute STEMI or NSTEMI event) chronic stable angina, peripheral vascular disease, stroke or TIA Exclusion Criteria: Inflammatory diseases and/or infections (except for the IMA-COVID-19 group); Tumors, immunological and/or hematological disorders; Ejection fraction less than 40%; Treatments with anti-inflammatory drugs, with the exception of low-dose aspirin, and antibiotic therapies up to 1 month before enrolment.
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Clinical and Imaging Biomarkers Associated With Plasma ad Cellular Determinants of Cardiovascular Disease at the Time of COVID 19

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