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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Cardiovascular Diseases

Treatments: Other: sample blood

Study type: Interventional

Funder types: Other

Identifiers

NCT05745753

3728

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Partecipants with cardiovascular disease

Experimental group

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.

Treatment:

Other: sample blood

Partecip with cardiovascular disease and affected by COVID-19

Experimental group

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.

Treatment:

Other: sample blood