Understanding heart injury in COVID-19 patients
Characterization and Prognostic Role of Myocardial Injury in Patients With COVID-19. The CardioCOVID Gemelli Study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05392088
This study is trying to understand how COVID-19 affects heart health in hospitalized patients, especially after they've been vaccinated, to help doctors predict and manage heart injury risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT05392088 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical predictors of myocardial injury in patients hospitalized with COVID-19, particularly after the introduction of vaccines. It will analyze both retrospective and prospective data to develop predictive models that assist clinicians in assessing the risk of myocardial injury early on. Additionally, the study will characterize cardiovascular outcomes in the post-acute phase of COVID-19 and investigate long-term clinical outcomes for patients who experienced myocardial injury, potentially leading to targeted therapies to reduce cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have been hospitalized with confirmed COVID-19 and have had high sensitivity Troponin I levels measured.
Not a fit: Patients under 18 years old or those without available Troponin I measurements during hospitalization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve early detection and management of myocardial injury in COVID-19 patients, ultimately reducing adverse cardiovascular outcomes.
How similar studies have performed: While some studies have explored cardiovascular outcomes in COVID-19, this study's specific focus on myocardial injury and long-term outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Overt COVID-19 infection (molecular nasopharyngeal swab positive for SARS-CoV-2 ≥1); * Patient with at least a high sensitivity Troponin I measured during hospitalization course. * Available data on vaccination. * Verbal informed consent Exclusion Criteria: * Age \<18 years; * Patient in whom at least one high sensitivity Troponin I value measured during the course of hospitalization is not available. * No data available on vaccination status.
Where this trial is running
Rome
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (RECRUITING)
Study contacts
- Principal investigator: Rocco A Montone, MD, PhD — Fondazione Policlinico Universitario A. Gemelli, IRCCS
- Study coordinator: Rocco A Montone, MD, PhD
- Email: roccoantonio.montone@policlinicogemelli.it
- Phone: +39-0630154187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocardial Injury, COVID-19