Exploring the link between small airway disease and cardiovascular disease in patients with chronic obstructive pulmonary disease

Assessing the relationship between cardiovascular and small airway disease and acute events in COPD: the ARCADIA study protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN49392136

Enrollment

500

Registered

2023-03-15

Start date

2023-01-31

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease (CVD) and small airway disease (SAD) in patients with chronic obstructive pulmonary disease (COPD) Respiratory

Interventions

The ARCADIA study is a prospective, multicenter, pilot, observational, cohort study that will be conducted in =20 pulmonary centers from all over Italy. The goal of this study is to enroll =500 patien

the secondary endpoints will be to assess mortality, exacerbation risk and exacerbation characteristics in the same patients.

Eligibility

Sex/Gender

All

Age

40 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Clinical and functional diagnosis of COPD 2. Forced expiratory volume in the 1st second (FEV1)/forced vital capacity (FVC) ratio <0.7 and/or FEV1/FVC (or FEV1/vital capacity [VC]) < lower limit of normal (LLN) 3. Clinical stability =3 months (no mild moderate or severe exacerbations) 4. Both genders 5. Age =40 years 6. Smoking history =10 p/y

Exclusion criteria

Exclusion criteria: 1. Previous or current history of bronchial asthma 2. Restrictive lung disease or interstitial lung disease 3. Active or under treatment neoplasms 4. Shift of inhalation therapy in the 3 months prior to study entry 5. Inability to perform reliable and repeatable pulmonary function tests 6. Oxygen therapy >18 hours a day 7. Diagnosed with clinically significant bronchiectasis (overt diagnosis of bronchiectasis on chest computed tomography [CT] which is the patient's primary diagnosis) 8. Severe obstructive sleep apnea syndrome (apnea/hypopnea index >30/h) 9. Pregnancy

Design outcomes

Primary

Measure	Time frame
Cardiovascular disease risk in patients with COPD affected by small airway disease (SAD) measured using a bespoke questionnaire at visit 2 (after 6±1 months from visit 1) and visit 3 (after 12±2 months from visit 1)	—

Secondary

Measure	Time frame
Mortality, exacerbation risk and exacerbation characteristics in the same patients measured using a bespoke questionnaire at visit 2 (after 6±1 months from visit 1) and visit 3 (after 12±2 months from visit 1)	—

Countries

Italy

Contacts

Public ContactElena Pistocchini

elena.pistocchini@uniroma2.it+39 06 2090 4656

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026