Clinical trial NCT05745753: Clinical and Imaging Biomarkers Associated With Plasma ad Cellular Determinants of Cardiovascular Disease at the Time of COVID 19
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Covid 19
Pneumonia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Assess cardiovascular risk
timeFrame: 6 months
Secondary outcomes:
measure: The prevalence of cardiovascular risk factors in chronic COVID 19 partecipants.
timeFrame: 6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References: