Cardiovascular Diseases, COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD exacerbation, Cardiovascular disease, Comorbidity, Diagnosis, Screening
Brief summary
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.
Detailed description
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.
Interventions
OTHERCardiologist evaluation
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.
Sponsors
Tel-Aviv Sourasky Medical Center
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
The interviewer in the 1, 3, 6 and 12 months phone call follow-up will be blinded to group allocation.
Intervention model description
Given the unique intervention, it is expected that the department's daily practices may change during the study due to exposure to the intervention (increased cardiovascular screening and treatment in COPD patients). This could directly impact the intervention's effectiveness. In addition, the quality of treatment and personnel in each department might affect the compliance with the cardiologists recommendations. Therefore, randomization will not be made at the individual or department level, but rather consecutive patients will first be recruited to the control group, followed by 3 weeks of wash-out, and then recruited for the intervention. COPD patients will be identified by their treating physicians and referred to the research team.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Documented COPD (based on lung function tests, symptoms and relevant treatment). * Aged 18-75 years. * Mentally competent to understand and follow medical recommendations.
Exclusion criteria
* Under 18 years of age. * Unable to provide consent. * Unstable concurrent disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular-related treatment change in 6 months | From enrollment to 6 months follow-up call | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of new cardiovascular comorbidity | From inclusion to hospital discharge | Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure. |
| Extended diagnosis of new cardiovascular comorbidity | At 6 months after enrollment. | Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure. |
| Adverse outcomes | At 3 and 6 months from study enrollment | Combined outcome of Major Adverse Cardiovascular Events (MACE - stroke, myocardial infarction, cardiovascular mortality) and readmissions or mortality due to COPD |
| MACE | At 3 and 6 months from enrollment | Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality. |
| Time to MACE | 6 months from enrollment | Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality |
| COPD exacerbations | 3 and 6 months from enrollment | 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. |
| COPD severe exacerbations | 6 months from study recruitment | Amount of COPD exacerbations that leads to hospitalization |
Countries
Israel
Outcome results
None listed