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Predictors of Cardiovascular Risk in Covid-19 Patients During Acute Disease and at Short Term Follow-up (CARDICoVRISK)

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ClinicalTrials.gov Identifier: NCT04371289
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Brief Summary:

Northern Italy, and particularly Lombardy, is one of the regions of the world mostly affected by COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To investigate the still largely unknown pathophysiology of this disease, we have built a consortium of Italian Hospitals to include a large cohort of COVID-19 patients from mild out-patients managed by GPs to inpatients developing mild, moderate or severe disease assessed both in hospital and at a 3-6 month follow-up visit). Consortium partners have a wide expertise to allow for 1) comprehensive assessment of risk factors for severe COVID-19 syndrome; 2) study the pathophysiology of its cardio-respiratory manifestations; 3) estimate risk scores also with artificial intelligence and 4) assess its clinical immunoinflammatory and cardiorespiratory sequelae in discharged patients at short term follow-up. To this aim, we will

  1. Enroll around 5500 COVID-19 patients (1000 outpatients and 4500 in-patients), which will allow to:

    1.1 Phenotype patients with COVID-19 of variable severity 1.2 Assess the prevalence of COVID-19 among GPs in relation with their use of PPE 1.3 Evaluate the impact of patients' demographic and clinical characteristics COVID-19 severity

  2. Use an electronic CRF (on RedCap) to record clinical, biohumoral and imaging data of inpatients with COVID-19 of various severity to explore the prognostic and pathophysiological role of immunologic factors, activation of blood coagulation, endothelial dysfunction, inflammatory response, genetic (ni particular X-linked), hormonal and metabolic factors, comorbidities and acute cardiac damage. Blood samples will be collected. We will also use machine learning techniques to develop multivariable models for patients' risk stratification
  3. A follow-up visit at 3-6 months after discharge will be performed to identify residual clinical consequences that might affect long-term prognosis.

Condition or disease
COVID-19 Cardiovascular Risk Factor

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Study Type : Observational
Estimated Enrollment : 5500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Risk in COVID-19 Patients: Metabolic, Prothrombotic and Proinflammatory Mechaninsms Associated With Outcome and With Cardiorespiratory Features During the Acute Viral Disease and at Short Term Follow-up
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : September 10, 2020

Group/Cohort
COVID-19 outpatients
Mild COVID-19 outpatients managed by General Practitioners in Northern Italy (Lombardy)
COVID-19 inpatients
Mild, moderate and severe inpatients managed in different Italian Hospitals, mostly in Northern Italy (Lombardy)



Primary Outcome Measures :
  1. Predictive modeling of in-hospital outcome [ Time Frame: 12 Months ]
    To obtain a multivariable model based on anthropometric, clinical and therapeutic variables that will allow to predict the development of severe COVID-19 and its complications

  2. Clinical, pathophysiological and molecular mechanisms [ Time Frame: 12 Months ]
    To Identify the role of selected clinical, pathophysiological and molecular mechanisms in the development of COVID-19 disease and its clinical manifestations of different severity

  3. Short -Term Sequelae [ Time Frame: 12 Months ]
    To Identify the clinical, immunological, inflammatory, viral, cardiorespiratory consequences of COVD-19 that may persist a few months after discharge and may affect mid- and long-term prognosis


Biospecimen Retention:   Samples With DNA
Blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients and hospitalized patients with confirmed COVID-19 infection, recruited by General Practitioners or in Italian hospitals (mostly in Northern Italy), respectively
Criteria

Inclusion Criteria:

  • Positivity to the test for COVID-19 and / or chest Xray or CT positive for interstitial pneumonia compatible with infection with this virus, regardless of the severity of the infection and the need or not for hospitalization
  • Informed consent freely granted also verbally

Exclusion Criteria:

  • Failure to satisfy the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371289


Contacts
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Contact: Gianfranco Parati, MD, PhD +390261911 ext 2949 gianfranco.parati@unimib.it

Locations
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Italy
Istituto Auxologico Italiano
Milan, Italy
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
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Study Director: Gianfranco Parati, MD, PhD Istituto Auxologico Italiano
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Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT04371289    
Other Study ID Numbers: CE_2020_03_26_02
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing individual participants data that underlie the results included in published articles, after deidentification
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication
Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be available for individual participant data meta-analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Auxologico Italiano:
Angiotensin receptor-blocker
ACE inhibitors drugs
Co-morbidities
Inflammatory cytokines
Genetic factors
Metabolic factors
Cardiac damage
Artificial Intelligence