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

NCT ID: NCT05745753

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-16
• Study Completion Date: 2024-01-15

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Partecipants with cardiovascular disease

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.

Group Type: EXPERIMENTAL

sample blood

Intervention Type: 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.

Partecip with cardiovascular disease and affected by COVID-19

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.

Group Type: EXPERIMENTAL

sample blood

Intervention Type: 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.

Interventions

sample blood

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.

Intervention Type: OTHER

Other Intervention Names

clinical history and peripheral blood sampling

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Pedicino Daniela

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

3728

Identifier Type: -

Identifier Source: org_study_id