This is a research study involving patients hospitalized for COPD flare-ups. Patients will be assigned using a non-randomized, sequential allocation strategy (a control cohort followed by an intervention cohort) to two groups: one group will only see a pulmonologist (lung doctor), and the other group will also be seen by a cardiologist (heart doctor) during their hospital stay. Both groups will fill out a questionnaire, and the pulmonologist will review their lung disease, adjust their treatment, and recommend follow-up care. The cardiologist will also assess the second group for heart diseases (like high cholesterol, diabetes, heart disease, high blood pressure, or heart failure) and start or adjust heart treatment if needed. Both groups will be followed up by phone 1, 3, 6 and 12 months later to check for changes in treatment, new heart problems, COPD flare-ups, or death.
This is a single-center, prospective study involving patients hospitalized for COPD exacerbation. Eligible patients will be identified either by the internal medicine department doctors or by reviewing the admission diagnoses of hospitalized patients in the hospital's database. After obtaining informed consent, the patients will be assigned into one of two sequential cohorts (a control cohort followed by an intervention cohort). Both groups will complete a background questionnaire and will be assessed by a pulmonologist during the hospitalization, who will focus on their lung disease, optimize basic treatment, and recommend follow-up as needed. The intervention group will undergo an additional evaluation by a cardiologist during the hospitalization, who will check for cardiovascular diseases (such as hyperlipidemia, diabetes, ischemic heart disease, hypertension, or heart failure) and adjust or start treatment according to new or existing diagnoses. Both groups will receive follow-up phone calls about 1, 3, 6, and 12 months later to evaluate any changes in treatment following the intervention, new diagnoses or events of cardiovascular diseases, COPD exacerbations, and mortality.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
150
The cardiology consultation will include the following: a structured interview (see Appendix A), physical examination, review of laboratory tests including HbA1c, lipid profile, BNP, ECG, and POCUS (point-of-care ultrasound) to assess heart contraction and valve function.
optimize basic treatment, and recommend continued follow-up as needed.
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Cardiovascular-related treatment change in 6 months
New pharmacological treatment or intervention (e.g., angiography, surgery) for cardiovascular disease, including diabetes, hypertension, dyslipidemia, ischemic heart disease, stroke, valvular disease, or heart failure compared to at inclusion.
Time frame: From enrollment to 6 months follow-up call
Diagnosis of new cardiovascular comorbidity
Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.
Time frame: From inclusion to hospital discharge
Extended diagnosis of new cardiovascular comorbidity
Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.
Time frame: At 6 months after enrollment.
Adverse outcomes
Combined outcome of Major Adverse Cardiovascular Events (MACE - stroke, myocardial infarction, cardiovascular mortality) and readmissions or mortality due to COPD
Time frame: At 3 and 6 months from study enrollment
MACE
Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality.
Time frame: At 3 and 6 months from enrollment
Time to MACE
Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality
Time frame: 6 months from enrollment
COPD exacerbations
Amount of COPD exacerbations, defined as an event characterized by an acute change in the patient's baseline dyspnoea, cough, and/or sputum that warrant a change in regular medication.
Time frame: 3 and 6 months from enrollment
COPD severe exacerbations
Amount of COPD exacerbations that leads to hospitalization
Time frame: 6 months from study recruitment
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