Cardiorespiratory Diagnostic Study

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT04939558
• Date of registration: 03/06/2021
• Prospective Registration: Yes
• Primary sponsor: Cambridge Respiratory Innovations Limited
• Public title: Cardiorespiratory Diagnostic Study CARES
• Scientific title: A Longitudinal Observational Study to Investigate the Patterns of Change in the Tidal Breathing CO2 Waveform, Measured Using the N-Tidal C Handset, in Patients With COPD Compared to Patients With Other Common Cardiorespiratory Conditions
• Date of first enrolment: June 2, 2021
• Target sample size: 740
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT04939558
• Study type: Observational [Patient Registry]

Countries of recruitment

United Kingdom

Contacts

• Name: Elango Vijaykumar, MBBS, FRCG
• Affiliation: Modality Partnership

• Name: Zishan Ali, MBBS BSc
• Affiliation: Modality Partnership

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > 18 years

- Healthy volunteer (with no previous or current chronic cardiorespiratory diagnoses)

One of the following cardiorespiratory diagnoses:

- COPD (GOLD 1, 2, 3 / A, B, C)*

- Asthma (mild to moderate, not labelled as severe)*

- Congestive cardiac failure*

- Anaemia (with at least 50% of participants recruited having no history of chronic
cardiorespiratory conditions)*

- Bronchiectasis (acquired or genetic, e.g. cystic fibrosis or other primary ciliary
dyskinesias)*

- Lung cancer (including rare types e.g. mesothelioma)*

- Interstitial Lung Disease (including pulmonary fibrosis pneumoconiosis, asbestosis,
sarcoidosis, amyloidosis)*

- Long COVID*

- Upper airway obstruction disorder*

- [Active pulmonary hypertension]

- [Extrinsic Allergic Alveolitis]

- [Active pulmonary embolism]

Exclusion Criteria:

- Participants who, in the opinion of the chief investigator, or their delegate, are
unlikely to comply with the requirements of the study;

- Diagnosis of neuromuscular disorders;

- Concurrent diagnosis of cardiorespiratory conditions (other than those listed in the
inclusion criteria above) that, in the opinion of the chief investigator, would impact
the conduct of the study

- Participants who are acutely unwell, e.g. active exacerbation, very short of breath
e.g. severe COPD (GOLD 4 / D) or end-stage IPF.

- Inability to give written informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anemia

Asthma

Bronchiectasis

Congestive Cardiac Failure

COPD

Healthy

Interstitial Lung Disease

Long COVID

Lung Cancer

Upper Respiratory Disease

Intervention(s)

Device: N-Tidal C handset

Primary Outcome(s)

Breath records from participants with Chronic Obstructive Pulmonary Disease (COPD) [Time Frame: 12 months from First Patient First Visit (FPFV)]

Secondary Outcome(s)

Breath records from Healthy volunteers (no previous or current cardiorespiratory diagnoses) [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Anaemia [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Asthma [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Bronchiectasis [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Congestive cardiac failure [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Interstitial Lung Disease [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Long COVID [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Lung cancer [Time Frame: 12 months from First Patient First Visit (FPFV)]

Breath records from participants with Upper airway obstruction disorder [Time Frame: 12 months from First Patient First Visit (FPFV)]

Secondary ID(s)

G001-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Innovate UK

National Institute for Health Research, United Kingdom