CardioVascular Disease Progression and Prognosis in COVID-19

Covid19 Clinical Trial

— CVP-Covid19  

Official title:

Cardiovascular Clinical Features and Cardiovascular Therapies in the Development, Progression and Outcome of Patients With SARS-Cov-2 Related Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04606732
• Other study ID #: CV_SPP_COVID19
• Status: Recruiting
• Start date: September 20, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Bologna
• Contact: Olivia Manfrini, MD
• Phone: +393355612175
• Email: olivia.manfrini[@]unibo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.

Description:

Members of the Steering Committee:

Olivia Manfrini (Università di Bologna, Italy) Raffaele Bugiardini (Università di Bologna, Italy) Stefano Nava (Università di Bologna, Italy) Elisabetta Poluzzi (Università di Bologna, Italy) Maria Carla Re (Università di Bologna, Italy) Caterina Vocale (Policlinico Sant'Orsola) Study Coordinator: Edina Cenko (Università di Bologna, Italy)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

hospitalization for COVID-19

Exclusion Criteria:

age <18 years

Related Conditions & MeSH terms

• Cardiovascular Diseases
• COVID-19
• Covid19

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Bergami M, Manfrini O, Nava S, Caramori G, Yoon J, Badimon L, Cenko E, David A, Demiri I, Dorobantu M, Fabin N, Gheorghe-Fronea O, Jankovic R, Kedev S, Ladjevic N, Lasica R, Loncar G, Mancuso G, Mendieta G, Milicic D, Mjehovic P, Pasalic M, Petrovic M, Po — View Citation

Bugiardini R, Nava S, Caramori G, Yoon J, Badimon L, Bergami M, Cenko E, David A, Demiri I, Dorobantu M, Fronea O, Jankovic R, Kedev S, Ladjevic N, Lasica R, Loncar G, Mancuso G, Mendieta G, Milicic D, Mjehovic P, Pasalic M, Petrovic M, Poposka L, Scarpon — View Citation

Cenko E, Badimon L, Bugiardini R, Claeys MJ, De Luca G, de Wit C, Derumeaux G, Dorobantu M, Duncker DJ, Eringa EC, Gorog DA, Hassager C, Heinzel FR, Huber K, Manfrini O, Milicic D, Oikonomou E, Padro T, Trifunovic-Zamaklar D, Vasiljevic-Pokrajcic Z, Vavlukis M, Vilahur G, Tousoulis D. Cardiovascular disease and COVID-19: a consensus paper from the ESC Working Group on Coronary Pathophysiology & Microcirculation, ESC Working Group on Thrombosis and the Association for Acute CardioVascular Care (ACVC), in collaboration with the European Heart Rhythm Association (EHRA). Cardiovasc Res. 2021 Dec 17;117(14):2705-2729. doi: 10.1093/cvr/cvab298. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All causes mortality	30 days
Primary	Mortality	All causes mortality	6 months
Primary	Mortality	All causes mortality	1 year