International Survey of Acute Coronavirus Syndromes-COVID-19

NCT05188612 | Recruiting

• 1 other identifier: ISACS-COVID-19
• Study Type: observational
• Target: 10,000
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Heart failure

  30 day, 6 -12 months

• Worsening renal function

  30 day, 6 -12 months

• Respiratory Insufficiency

  30 day, 6 -12 months

• Pneumonia

  30 day, 6 -12 months

• Sepsis

  30 day, 6 -12 months

Study Arms (10)

Male

Non-interventional patient registry

Combination Product: Observational (registry)

Female

Non-interventional patient registry

Combination Product: Observational (registry)

Elderly

Non-interventional patient registry

Combination Product: Observational (registry)

Hypertension

Non-interventional patient registry

Combination Product: Observational (registry)

Diabetes

Non-interventional patient registry

Combination Product: Observational (registry)

Dyslipidemias

Non-interventional patient registry

Combination Product: Observational (registry)

Smoking

Non-interventional patient registry

Combination Product: Observational (registry)

Kidney Disease

Non-interventional patient registry

Combination Product: Observational (registry)

Heart Diseases

Non-interventional patient registry

Combination Product: Observational (registry)

Vascular diseases

Non-interventional patient registry

Combination Product: Observational (registry)

Interventions

Observational (registry) COMBINATION_PRODUCT

Observational (Patient Registry)

Diabetes; Dyslipidemias; Elderly; Female; Heart Diseases; Hypertension; Kidney Disease; Male; Smoking; Vascular diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Confirmed diagnosis of COVID-19 infection.

You may qualify if:

• Age ≥18 years (male or female)
• Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.

You may not qualify if:

• Underage or not able to give informed consent

Sponsors & Collaborators

• University of Bologna: lead
• Associazione Per La Ricerca Cardiologica (Roma): collaborator

Study Sites (2)

University of Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

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

Barcelona, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 36651866 BACKGROUND

• 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.

  PMID: 37449568 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

COVID-19

Interventions

Registries

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Olivia Manfrini, MD

  University of Bologna

  STUDY DIRECTOR

• Lina Badimon, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Raffaele Bugiardini, MD

CONTACT

+39 051 347290; raffaele.bugiardini@unibo.it

Olivia Manfrini, MD

CONTACT

+39 051 2143778; olivia.manfrini@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: January 12, 2022
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (1); ES (1)