COINCIDE: Cardineurovascular dIsease and Obstructive Airway Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVASCage GmbH
About this trial
Patients with chronic obstructive pulmonary disease (COPD) and severe asthma frequently present with cardiovascular comorbidities that contribute substantially to morbidity and mortality. Early identification and appropriate management of cardiovascular disease are increasingly recognized as important components of comprehensive care for patients with obstructive airway diseases.
The COINCIDE study is a prospective longitudinal observational cohort study conducted at the Department of Pulmonology, Medical University of Innsbruck. The study aims to systematically document cardiovascular comorbidities in patients with COPD and severe asthma and to evaluate their association with disease progression, therapeutic management, exacerbation rates, symptom burden, and pulmonary function over time.
Clinical, functional, laboratory, and imaging data obtained as part of routine clinical care will be collected prospectively during two study visits separated by approximately 24 months. Up to 350 adult participants will be enrolled and followed over a period of five years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 years or older.
Diagnosis of COPD GOLD Group B or E according to current GOLD recommendations, or severe asthma according to current GINA recommendations.
Receiving care at the specialized pulmonary outpatient clinic of the Department of Internal Medicine II, Medical University of Innsbruck.
Ability to provide written informed consent.
Disqualifiers
Age below 18 years.
Inability or unwillingness to participate in study procedures.
Inability or unwillingness to provide written informed consent.
Planned transfer of care preventing longitudinal follow-up.
Trial population
The study population consists of adult patients (≥18 years) with a diagnosis of COPD GOLD Group B or E or severe asthma according to current GOLD and GINA recommendations. Participants are recruited from the specialized pulmonary outpatient clinic of the Department of Internal Medicine II, Medical University of Innsbruck, and receive routine clinical care. Patients are followed prospectively to assess cardiovascular comorbidities and their impact on clinical outcomes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Routine Clinical Care
Other interventionParticipants receive routine medical care according to local standards of care. No study-specific intervention, treatment allocation, or diagnostic procedure is performed.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Prevalence and characterization of cardiovascular comorbidities
Assessment of the prevalence, type, and distribution of cardiovascular comorbidities in patients with COPD and severe asthma based on clinical, laboratory, and imaging findings obtained during routine care.
Time frame
Baseline and 24 monthsSecondary outcomes
1
Exacerbation Frequency
Association between cardiovascular comorbidities and frequency of respiratory exacerbations.
Time frame
24 months2
Symptom Burden
Association between cardiovascular comorbidities and respiratory symptom burden as documented in routine clinical assessments.
Time frame
24 months3
Pulmonary Function
Association between cardiovascular comorbidities and pulmonary function parameters.
Time frame
Baseline and 24 months4
Treatment Modifications
Assessment of changes in therapeutic management associated with the identification and characterization of cardiovascular comorbidities.
Time frame
24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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