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| Name | Class |
|---|---|
| Associazione Per La Ricerca Cardiologica (Roma) | UNKNOWN |
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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.
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:
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.
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:
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.
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:
Italy: Local PI: Stefano Nava (University of Bologna)
Other Investigators:
Macedonia: Local PI: Sasko Kedev and Marija Vavlukis (University "Ss. Cyril and Methodius")
Other Investigators:
Serbia: Local PI: Marija Zdravkovic (Hospital Medical Center Bezanijska kosa, Belgrade), Zorana Vasiljevic (University of Belgrade)
Other Investigators:
Spain: Local PI: Teresa Padro (IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona)
Other Investigators:
United Kingdom: Local PI: Charalambos Antoniades (Oxford University)
Other Investigators:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male | Non-interventional patient registry |
| |
| Female | Non-interventional patient registry |
| |
| Elderly | Non-interventional patient registry |
| |
| Hypertension | Non-interventional patient registry |
| |
| Diabetes | Non-interventional patient registry |
| |
| Dyslipidemias | Non-interventional patient registry |
| |
| Smoking |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational (registry) | Combination Product | Observational (Patient Registry) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death all cause | Occurrence of all cause death | 30-day |
| Death all cause | Occurrence of all cause death | 6 month |
| Death all cause | Occurrence of all cause death | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Heart failure | Occurrence of heart failure or worsening of preexisting heart failure (According to the attending physician) | 30 day, 6 -12 months |
| Worsening renal function | Occurrence of kidney disease or worsening of preexisting kidney failure (According to the attending physician) |
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Inclusion Criteria:
Exclusion Criteria:
• Underage or not able to give informed consent
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Confirmed diagnosis of COVID-19 infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raffaele Bugiardini, MD | Contact | +39 051 347290 | raffaele.bugiardini@unibo.it | |
| Olivia Manfrini, MD | Contact | +39 051 2143778 | olivia.manfrini@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Olivia Manfrini, MD | University of Bologna | Study Director |
| Lina Badimon, PhD | IR-Hospital de la Santa Creu i Sant Pau, UAB, Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36651866 | Background | 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, Scarpone M, Stefanovic M, van der Schaar M, Vasiljevic Z, Vavlukis M, Vega Pittao ML, Vukomanovic V, Zdravkovic M, Manfrini O. Sex differences and disparities in cardiovascular outcomes of COVID-19. Cardiovasc Res. 2023 May 22;119(5):1190-1201. doi: 10.1093/cvr/cvad011. | |
| 37449568 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
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Databases with significant genomic data (e.g., genome-wide association studies, medical sequencing, molecular diagnostic assays), are expected to be deposited as well. Likewise, physical bio-samples can be included in the ISACS-COVID-19 registry
Non-interventional patient registry |
|
| Kidney Disease | Non-interventional patient registry |
|
| Heart Diseases | Non-interventional patient registry |
|
| Vascular diseases | Non-interventional patient registry |
|
| 30 day, 6 -12 months |
| Respiratory Insufficiency | Occurrence of respiratory insufficiency or worsening of preexisting respiratory insufficiency (According to the attending physician) | 30 day, 6 -12 months |
| Pneumonia | Occurrence of pneumonia (According to the attending physician) | 30 day, 6 -12 months |
| Sepsis | Occurrence of sepsis (According to the attending physician) | 30 day, 6 -12 months |
| Systemic Inflammatory Response Syndrome (SIRS) | Occurrence of SIRS (According to the attending physician) | 30 day, 6 -12 months |
| Thrombosis (arterial, venous) | Occurrence of thrombosis and thromboembolism (According to the attending physician) | 30 day, 6 -12 months |
| Clinically relevant bleeding | Occurrence of clinically relevant bleeding (According to the attending physician) | 30 day, 6 -12 months |
| Activity Daily Living status | (According to the attending physician) | 30 day, 6 -12 months |
| Depression status | (According to the attending physician) | 30 day, 6 -12 months |
| IR-Hospital de la Santa Creu i Sant Pau, UAB | Recruiting | Barcelona | Spain |
|
| Derived |
| 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, Poposka L, Scarpone M, Stefanovic M, van der Schaar M, Vasiljevic Z, Vavlukis M, Vega Pittao ML, Vukomanovic V, Zdravkovic M, Bugiardini R. Relationship Between Azithromycin and Cardiovascular Outcomes in Unvaccinated Patients With COVID-19 and Preexisting Cardiovascular Disease. J Am Heart Assoc. 2023 Jul 18;12(14):e028939. doi: 10.1161/JAHA.122.028939. Epub 2023 Jul 14. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |