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

NCT05745753 | Unknown

• 1 other identifier: 3728
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Covid 19; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (1)

• The prevalence of cardiovascular risk factors in chronic COVID 19 partecipants.

  6 months

Study Arms (2)

Partecipants with cardiovascular disease

EXPERIMENTAL

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.

Other: sample blood

Partecip with cardiovascular disease and affected by COVID-19

EXPERIMENTAL

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.

Other: sample blood

Interventions

sample blood OTHER

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.

Also known as: clinical history and peripheral blood sampling

Partecip with cardiovascular disease and affected by COVID-19; Partecipants with cardiovascular disease

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Cardiovascular Diseases; COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: February 27, 2023
• Study Start: January 16, 2021
• Primary Completion: July 15, 2021
• Study Completion: January 15, 2024
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

IT (1)