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COINCIDE: Cardineurovascular dIsease and Obstructive Airway Disease

NCT07856667 — Not yet recruiting, 350 participants, VASCage GmbH

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Cardineurovascular Disease and Obstructive Airway Disease (COINCIDE): A Prospective Longitudinal Observational Cohort Study of Cardiovascular Comorbidities in Patients With COPD and Severe Asthma

RegistryNCT07856667, acronym COINCIDE
StatusNot yet recruiting
Study typeObservational
Enrollment350 (Estimated)
SponsorVASCage GmbH (Other)
ConditionsChronic Obstructive Pulmonary Disease (COPD), Severe Asthma, Cardiovascular Diseases
InterventionsRoutine Clinical Care (Other)
Datesstart 2026-10-15 (estimated), primary completion 2031-05-15 (estimated), completion 2031-06-15 (estimated), first posted 2026-10-02, last updated 2026-10-09

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-Summary

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.

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+Detailed description

Cardiovascular comorbidities are among the major determinants of morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) and severe asthma. Despite guideline recommendations, systematic assessment and management of cardiovascular disease in these patient populations remain heterogeneous in routine clinical practice.

The primary objective of the COINCIDE study is to characterize the prevalence and spectrum of cardiovascular comorbidities in adult patients with COPD or severe asthma treated at a tertiary pulmonary outpatient clinic. Furthermore, the study aims to evaluate the relationship between cardiovascular comorbidities and clinical outcomes, including exacerbation frequency, symptom burden, pulmonary function, and treatment strategies.

This is a single-center, prospective, longitudinal observational cohort study conducted at the Department of Pulmonology, Department of Internal Medicine II, Medical University of Innsbruck, Austria. Clinical, functional, laboratory, and imaging findings obtained during routine care will be collected in a structured manner and analyzed longitudinally.

Participants will undergo study assessments at baseline and after approximately 24 months. The study is planned to enroll up to 350 adult patients and will be conducted over five years.

+Arms and interventions

  • Routine Clinical Care (Other): Participants receive routine medical care according to local standards of care. No study-specific intervention, treatment allocation, or diagnostic procedure is performed.

+Outcome measures

Primary outcomes

  • Prevalence and characterization of cardiovascular comorbidities [Baseline and 24 months]: 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.

Secondary outcomes

  • Exacerbation Frequency [24 months]: Association between cardiovascular comorbidities and frequency of respiratory exacerbations.
  • Symptom Burden [24 months]: Association between cardiovascular comorbidities and respiratory symptom burden as documented in routine clinical assessments.
  • Pulmonary Function [Baseline and 24 months]: Association between cardiovascular comorbidities and pulmonary function parameters.
  • Treatment Modifications [24 months]: Assessment of changes in therapeutic management associated with the identification and characterization of cardiovascular comorbidities.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Pregnancy.

+Investigators

My Notes