Official Title
International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19
Brief Summary

In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existingand further centers of the same geographic areas to support clinical research to prevent,and treat the COVID-19 illness. These efforts are made possible by the generouscontributions of clinical research volunteers in some of the countries participating tothe prior acute coronary syndrome network.

Detailed Description

To address existing gaps in knowledge on CVD among European countries at different income
levels, a collaboration of outcomes-oriented researchers from the University of Bologna
partnered with Central and East European (CEE) countries researchers to conduct the
International Survey of Acute Coronary Syndromes in Transitional Countries (ISACS-TC)
investigating underlying threats in patients' CVD health status (NCT01218776).

In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing
and further centers of the same geographic areas to support clinical research to prevent,
and treat the COVID-19 illness. These efforts are made possible by the generous
contributions of clinical research volunteers in some of the countries participating to
the prior acute coronary syndrome network.

Scientific and clinical evidence is evolving on the effects of COVID-19, which can affect
multiple organ systems. As, so the COVID-19 pandemic underscores the urgent need for
coordination, collaboration, and information-sharing among researchers worldwide.
Researchers of many disciplines have, therefore, joined the ISACS-TC investigators to
build a multi-disciplinary registry investigating the impact of COVID-19.

Projects should be mainly focused on topics related to:

1. The impact of COVID-19 infection on patients who have attended any health care
center (within hospital beds), and who have been discharged or have died at the time
of the evaluation. The main objective of this task is to carefully characterize the
clinical profile of patients infected with COVID-19 in order to develop a simple
prognostic clinical score allowing rapid logistic decision making such as discharge
with follow-up, referral to provisional hospitals, or admission to hospital centers
with advanced equipment or specialized procedures and techniques. A secondary
objective of this retrospective analysis is to evaluate the risk-adjusted influence
of prior evidence-based treatments and comorbidities on patients infected with the
disease.

2. The second issue relates to the long-term health consequences after COVID-19
infection. Early reports suggest residual effects of SARS-CoV-2 infection, such as
fatigue, dyspnea, chest pain, cognitive disturbances, arthralgia, and decline in
quality of life. However, the evidence is still scarce. Prior studies did not take
into account the vast majority of patients with a mild course of the infection. As
well, the definition of the post-acute COVID-19 timeline is evolving. Today we may
summarize the post-acute COVID-19 syndrome into two categories:

- subacute or ongoing symptomatic COVID-19, which includes symptoms and
abnormalities present from 4-12 weeks beyond acute COVID-19;

- chronic or post-COVID-19 syndrome, which includes symptoms and abnormalities
persisting or present beyond 12 weeks of the onset of acute COVID-19 and not
attributable to alternative diagnoses. Systematic study of sequelae after
recovery from acute COVID-19 is needed to develop an evidence-based
multidisciplinary team approach for caring for these patients, and to inform
research priorities.

One trained physician will critically review the patients' reported symptoms and will
assess SARS-CoV-2 IgG at each visit. In addition, wherever needed, the investigators will
investigate the daily living status of survivors of COVID-19 using telephone interview
questionnaires including Activity Daily Living (ADL), Self-rating Depression Scale (SDS),
and New York Heart Association (NYHA) functional class.

- Sponsor: Raffaele Bugiardini (Principal Investigator; PI) - University of Bologna

- Co-PI Investigator (Clinical Research): Olivia Manfrini (University of Bologna)

- Co-PI Investigator (Translational Research): Lina Badimon (IR-Hospital de la Santa
Creu i Sant Pau, UAB, Barcelona)

- Collaborator: Associazione Per La Ricerca Cardiologica, Roma

National Investigators:

Bosnia and Herzegovina: Local PI: Mirza Dilic (Clinical Center University of Sarajevo)

Croatia: Local PI: Davor Miličić (University Hospital Center Zagreb)

Other Investigators:

- Marijan Pašalić (University Hospital Center Zagreb)

- Petra Mjehović (University Hospital Center Zagreb)

Italy: Local PI: Stefano Nava (University of Bologna)

Other Investigators:

- Gaetano Caramori (University of Messina)

- Antonio David, (University of Messina)

- Giuseppe Mancuso (University of Messina)

- Maria Laura Vega Pitao (University of Bologna)

- Giulia Panzuti (University of Bologna)

- Edina Cenko (University of Bologna)

- Maria Bergami (University of Bologna)

- Marialuisa Scarpone (University of Bologna)

- Antonio Spanevello (IRCCS Maugeri)

- Fabio Angeli (IRCCS Maugeri)

- Dina Visca (IRCCS Maugeri)

- Martina Zappa (IRCCS Maugeri)

- Paolo Emilio Puddu (Associazione Per La Ricerca Cardiologica, Roma)

Macedonia: Local PI: Sasko Kedev and Marija Vavlukis (University "Ss. Cyril and
Methodius")

Other Investigators:

- Lidija Poposka (University Clinic of Cardiology)

- Milena Stefanovic (University Clinic of Infectious Diseases)

- Ilir Demiri (University Clinic of Infectious Diseases) Romania: Local PI: Maria
Dorobantu (Emergency Clinical Hospital of Bucharest) Other Investigators: Oana
Fronea Gheorghe (Emergency Clinical Hospital of Bucharest)

Serbia: Local PI: Marija Zdravkovic (Hospital Medical Center Bezanijska kosa, Belgrade),
Zorana Vasiljevic (University of Belgrade)

Other Investigators:

- Nebojsa Ladjevic, Clinic for Anesthesia, Covid Hospital Batajnica, Belgrade

- Radmilo Jankovic (Clinical Center Nis)

- Goran Loncar (Institute for Cardiovascular Diseases Dedinje)

- Ratko Lasica (Clinical Center of Serbia)

- Miodrag Petrović (Institute for Cardiovascular Diseases Sremska Kamenica, Novi Sad)

- Vlada Vukomanovic (Clinical Hospital Center Dragiša Mišković Belgrade)

- Dubravka Rajic (Clinical Center of Serbia)

- Ana Uscumlic (Clinical Center of Serbia)

- Sanja Stankovic (Clinical Center of Serbia)

Spain: Local PI: Teresa Padro (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)

Other Investigators:

- Guiomar Mendieta ( CNIC, Madrid)

- Rosa Suades (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)

- Gemma Vilahur (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)

United Kingdom: Local PI: Charalambos Antoniades (Oxford University)

Other Investigators:

- Maria Lyasheva (University of Oxford)

- Lucy Kingham (University of Oxford)

- Christos Kotanidis (University of Oxford)

- Cheng Xie (University of Oxford)

Recruiting
COVID-19

Combination Product: Observational (registry)

Observational (Patient Registry)

Eligibility Criteria

Inclusion Criteria:

- Age ≥18 years (male or female)

- Patients admitted to any hospital center with a confirmed diagnosis of COVID-19
infection.

Exclusion Criteria:

• Underage or not able to give informed consent

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Spain
Locations

University of Bologna
Bologna, Italy

IR-Hospital de la Santa Creu i Sant Pau, UAB
Barcelona, Spain

Contacts

Raffaele Bugiardini, MD
+39 051 347290
raffaele.bugiardini@unibo.it

Olivia Manfrini, MD
+39 051 2143778
olivia.manfrini@unibo.it

Associazione Per La Ricerca Cardiologica (Roma)
NCT Number
MeSH Terms
COVID-19