Cardiovascular Assessment and Treatment During COPD Exacerbation to Improve Diagnosis and Outcomes (CATCH)

Early Cardiovascular Risk Assessment of Patients With COPD During Respiratory Exacerbation for the Identification and Treatment of Cardiovascular Comorbidity

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; COPD (Chronic Obstructive Pulmonary Disease)
• Intervention / Treatment: Other: Cardiologist evaluation; Other: Pulmonologist evaluation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ophir Freund, MD; Phone Number: +972-545-305648; Email: Ophirf@tlvmc.gov.il

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel-Aviv Sourasky Medical Center
    • Contact: Ophir Freund, MD; Phone Number: +972-545305648; Email: ophir068@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Cardiologist 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.; Other: Pulmonologist evaluation; optimize basic treatment, and recommend continued follow-up as needed.
Active Comparator: Control; 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.	Other: Pulmonologist evaluation; optimize basic treatment, and recommend continued follow-up as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: AstraZeneca

Publications and helpful links

General Publications

• 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.
• 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
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Screening; Diagnosis; Comorbidity; COPD exacerbation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Disease
• Other Study ID Numbers: 0510-24-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing is not permitted as per our institution review board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No