Cardiovascular Diseases (CVD), Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic obstructive pulmonary disease, COPD, Cardiovascular disease, CVD, Protocol, Real-World Data
Brief summary
COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. HELICOPD is a national, multicenter, prospective, non-interventional study designed to contribute to better understanding and depicting the demographic and clinical characteristics of this population, the COPD- and CVD-related adverse events in a two-years period, their quality of life and the healthcare resources use. The study is initiated and coordinated by the Hellenic Thoracic Society.
Interventions
None listed
Sponsors
Hellenic Thoracic Society
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Patients should cumulatively meet the following three (3) criteria to be enrolled in the study: 1. To have been diagnosed with chronic obstructive pulmonary disease and at least one cardiovascular comorbidity (heart failure, atherosclerotic cardiovascular disease, atrial Fibrillation, severe valvular disease) 2. Adults aged \>35 years at the time of inclusion in the study, 3. With signed informed consent for their participation in the study.
Exclusion criteria
Patients with the below limitations are not eligible to participate in the study Patients: 1. Without at least one cardiovascular comorbidity, 2. With history of lung cancer 3. With any other active malignancy and undergoing treatment (chemotherapy/radiotherapy/immunotherapy) 4. With any thoracic or abdominal surgery planned during study follow-up period 5. With participation in any COPD-related interventional study at study entry or during study duration. 6. Without signed informed consent for their participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of moderate or severe COPD exacerbations | Up to 24 months | Moderate COPD exacerbation: typically requires outpatient management, it is characterized by an increased need for medication, specifically the use of systemic corticosteroids and/or antibiotics. Severe COPD exacerbation: indicated by an acute worsening of symptoms that requires hospitalization. |
| Number of cardiovascular complications/outcomes | Up to 24 months | Cardiovascular complications/outcomes, including a) acute coronary syndrome, b) ischemic stroke, c) pulmonary embolism, d) reperfusion, e) worsening of heart failure that required a visit to the Emergency Department (ED) or hospitalization (short or longer), f) other hospitalization in a cardiology clinic (causes other than acute coronary syndrome, reperfusion, and heart failure), g) death related to cardiovascular disease. |
Secondary
| Measure | Time frame |
|---|---|
| Unscheduled hospital admission due to COPD | Up to 24 months |
| Unscheduled hospital admission due to any other reason | Up to 24 months |
Countries
Greece
Contacts
CONTACTStylianos Loukides
CONTACTAndriana Tsimpouki
PRINCIPAL_INVESTIGATORGeorgios Hillas
5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, Greece
PRINCIPAL_INVESTIGATORPaschalis Steiropoulos
Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
Outcome results
None listed