The HELlenic Thoracic Society Initiative for CΟPD and CVD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 900
- Locations
- 2
- Primary Endpoint
- Number of moderate or severe COPD exacerbations
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of moderate or severe COPD exacerbations
Time Frame: 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
Time Frame: 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 Outcomes
- Unscheduled hospital admission due to COPD(Up to 24 months)
- Unscheduled hospital admission due to any other reason(Up to 24 months)