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Clinical Trials/NCT05745753
NCT05745753
Active, not recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country120 target enrollmentJanuary 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
120
Locations
1
Primary Endpoint
Assess cardiovascular risk
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2021
End Date
January 15, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pedicino Daniela

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Outcomes

Primary Outcomes

Assess cardiovascular risk

Time Frame: 6 months

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 Outcomes

  • The prevalence of cardiovascular risk factors in chronic COVID 19 partecipants.(6 months)

Study Sites (1)

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