Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-01-17 @ 7:57 PM
Study NCT ID:
NCT06723795
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Assessment and Treatment During COPD Exacerbation to Improve Diagnosis and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The interviewer in the 1, 3, 6 and 12 months phone call follow-up will be blinded to group allocation.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.\n\nCOPD patients will be identified by their treating physicians and referred to the research team."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2024-12-04', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to COPD exacerbation', 'timeFrame': '6 moths from enrollment', 'description': "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."}, {'measure': 'Adherence to new treatment', 'timeFrame': '6 months from enrollment', 'description': 'Adherence to newly initiated pharmacological treatment from the study intervention'}, {'measure': 'Smoking cessation', 'timeFrame': '6 and 3 months from enrollment', 'description': 'Rates of smoking cessation between the intervention and control groups among smokers'}, {'measure': 'Specialists follow-up', 'timeFrame': '6 months from enrollment', 'description': 'Rate of patients with cardiologist and pulmonologist visits'}, {'measure': 'Post-Hoc analysis - Treatment', 'timeFrame': '12 months from recruitment', 'description': '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.'}, {'measure': 'Post-HOC analysis - diagnoses', 'timeFrame': '12 months from recruitment', 'description': 'Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.'}, {'measure': 'Post-HOC analysis - COPD exacerbations', 'timeFrame': '12 months from recruitment', 'description': 'COPD exacerbations requiring steroids or hospital arrival'}, {'measure': 'Post-HOC analysis - MACE', 'timeFrame': '12 months from recruitment', 'description': 'Occurance of MACE between the intervention and control'}], 'primaryOutcomes': [{'measure': 'Cardiovascular-related treatment change in 6 months', 'timeFrame': 'From enrollment to 6 months follow-up call', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of new cardiovascular comorbidity', 'timeFrame': 'From inclusion to hospital discharge', 'description': 'Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.'}, {'measure': 'Extended diagnosis of new cardiovascular comorbidity', 'timeFrame': 'At 6 months after enrollment.', 'description': 'Identification of new cardiovascular comorbidities, including diabetes, dyslipidemia, ischemic heart disease, valvular disease, or heart failure.'}, {'measure': 'Adverse outcomes', 'timeFrame': 'At 3 and 6 months from study enrollment', 'description': 'Combined outcome of Major Adverse Cardiovascular Events (MACE - stroke, myocardial infarction, cardiovascular mortality) and readmissions or mortality due to COPD'}, {'measure': 'MACE', 'timeFrame': 'At 3 and 6 months from enrollment', 'description': 'Occurrence of MACE - MACE - stroke, myocardial infarction, cardiovascular mortality.'}, {'measure': 'Time to MACE', 'timeFrame': '6 months from enrollment', 'description': 'Time from enrollment to first MACE - stroke, myocardial infarction, cardiovascular mortality'}, {'measure': 'COPD exacerbations', 'timeFrame': '3 and 6 months from enrollment', 'description': "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."}, {'measure': 'COPD severe exacerbations', 'timeFrame': '6 months from study recruitment', 'description': 'Amount of COPD exacerbations that leads to hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD exacerbation', 'Cardiovascular disease', 'Comorbidity', 'Diagnosis', 'Screening'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '37990197', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35007497', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20871122', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nBoth 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.\n\nBoth 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented COPD (based on lung function tests, symptoms and relevant treatment).\n* Aged 18-75 years.\n* Mentally competent to understand and follow medical recommendations.\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* Unable to provide consent.\n* Unstable concurrent disease.'}, 'identificationModule': {'nctId': 'NCT06723795', 'acronym': 'CATCH', 'briefTitle': 'Cardiovascular Assessment and Treatment During COPD Exacerbation to Improve Diagnosis and Outcomes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Early Cardiovascular Risk Assessment of Patients With COPD During Respiratory Exacerbation for the Identification and Treatment of Cardiovascular Comorbidity', 'orgStudyIdInfo': {'id': '0510-24-TLV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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.', 'interventionNames': ['Other: Cardiologist evaluation', 'Other: Pulmonologist evaluation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Other: Pulmonologist evaluation']}], 'interventions': [{'name': 'Cardiologist evaluation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention']}, {'name': 'Pulmonologist evaluation', 'type': 'OTHER', 'description': 'optimize basic treatment, and recommend continued follow-up as needed.', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ophir Freund, MD', 'role': 'CONTACT', 'email': 'ophir068@gmail.com', 'phone': '+972-545305648'}], 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Ophir Freund, MD', 'role': 'CONTACT', 'email': 'Ophirf@tlvmc.gov.il', 'phone': '+972-545-305648'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD sharing is not permitted as per our institution review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}