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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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This is a research study involving patients hospitalized for COPD flare-ups. Patients will be randomly assigned 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, randomized 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 randomized into two groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients will be evaluated by a pulmonologist during their admission, in addition to a cardiologist, aiming to identify cardiovascular comorbidities including dyslipidemia, diabetes, hypertension, ischemic heart disease, heart failure, valvular disease, personal or family history of ischemic heart disease, and smoking. Part of the evaluation will include assessing the management of diagnosed cardiovascular conditions. Finally, recommendations for further investigation or initiation of drug treatment will be made. |
|
| Control | Active Comparator | Patients will be evaluated by a pulmonologist during their hospitalization, who will focus on their pulmonary condition, optimize basic treatment, and recommend continued follow-up as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiologist evaluation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6 months follow-up call |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of new cardiovascular comorbidity | Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure. | From inclusion to hospital discharge |
| Extended diagnosis of new cardiovascular comorbidity |
| Measure | Description | Time Frame |
|---|---|---|
| Time to COPD exacerbation | Time to COPD exacerbation, defined as an event characterized by an acute change in the patient's baseline dyspnea, cough, and/or sputum that warrant a change in regular medication. | 6 moths from enrollment |
| Adherence to new treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Vogelmeier C, Simons S, Garbe E, et al. Increased risk of severe cardiovascular events following exacerbations of COPD: a multi-database cohort study. Eur Respir J. 2023;62(suppl 67). doi:10.1183/13993003.congress-2023.PA3013 | ||
| 37990197 | Result | Swart KMA, Baak BN, Lemmens L, Penning-van Beest FJA, Bengtsson C, Lobier M, Hoti F, Vojinovic D, van Burk L, Rhodes K, Garbe E, Herings RMC, Nordon C, Simons SO. Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands. Respir Res. 2023 Nov 21;24(1):293. doi: 10.1186/s12931-023-02601-4. | |
| 35007497 |
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IPD sharing is not permitted as per our institution review board.
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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.
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The interviewer in the 1, 3, 6 and 12 months phone call follow-up will be blinded to group allocation.
|
| Pulmonologist evaluation | Other | optimize basic treatment, and recommend continued follow-up as needed. |
|
Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure. |
| 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 | At 3 and 6 months from study enrollment |
| MACE | Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality. | At 3 and 6 months from enrollment |
| Time to MACE | Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality | 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. | 3 and 6 months from enrollment |
| COPD severe exacerbations | Amount of COPD exacerbations that leads to hospitalization | 6 months from study recruitment |
Adherence to newly initiated pharmacological treatment from the study intervention |
| 6 months from enrollment |
| Smoking cessation | Rates of smoking cessation between the intervention and control groups among smokers | 6 and 3 months from enrollment |
| Specialists follow-up | Rate of patients with cardiologist and pulmonologist visits | 6 months from enrollment |
| Post-Hoc analysis - Treatment | 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. | 12 months from recruitment |
| Post-HOC analysis - diagnoses | Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure. | 12 months from recruitment |
| Post-HOC analysis - COPD exacerbations | COPD exacerbations requiring steroids or hospital arrival | 12 months from recruitment |
| Post-HOC analysis - MACE | Occurance of MACE between the intervention and control | 12 months from recruitment |
| Result |
| Hawkins NM, Peterson S, Ezzat AM, Vijh R, Virani SA, Gibb A, Mancini GBJ, Wong ST. Control of Cardiovascular Risk Factors in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2022 Jul;19(7):1102-1111. doi: 10.1513/AnnalsATS.202104-463OC. |
| 20871122 | Result | Feary JR, Rodrigues LC, Smith CJ, Hubbard RB, Gibson JE. Prevalence of major comorbidities in subjects with COPD and incidence of myocardial infarction and stroke: a comprehensive analysis using data from primary care. Thorax. 2010 Nov;65(11):956-62. doi: 10.1136/thx.2009.128082. Epub 2010 Sep 25. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002318 | Cardiovascular Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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