Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD
Brief summary
The purpose of the LINQ™ for COPD study is to characterize Reveal LINQ™ derived data from patients with COPD by assessing the relationship between changes in LINQ™ derived data with COPD exacerbation events.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is progressive and currently incurable and refers to a collection of diseases that lead to the key feature of irreversible airflow limitation and breathing related problems. Of those with COPD, 46% experienced at least one exacerbation within the previous year and 19% needed hospitalization. The financial burden of COPD is also evident, in that over $32 billion was spent for COPD care in the United States in 2010 and it is expected to be close to $50 billion in 2020. Reducing healthcare utilization associated with COPD patient management (i.e. short-term readmission and chronic disease management) is a critically important unmet need for patients, caregivers, and hospitals. Early detection, prevention, and treatment of COPD exacerbation would aim to reduce this high morbidity and cost. To help reduce these exacerbations and improve disease management, sensors in a minimally invasive device can be used to identify factors that are associated with exacerbations.
Interventions
DEVICEReveal LINQ
Insertion of Reveal LINQ device to characterize collected data from patients with COPD.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 45 years old * Patient (or patient's legally authorized representative) is willing and able to provide written informed consent * Patient is willing and able to comply with the protocol, including follow-up visits, electronic diary submissions and CareLink transmissions * FEV1 (post bronchodilator) ≤ 70% of predicted * Current or former smoker with lifetime cigarette consumption of \> 10 pack-years * One COPD exacerbation in the previous 12 months requiring hospitalization, urgent care or emergency department visit for respiratory illness OR Two COPD exacerbations within the previous 12 months requiring antibiotics and/or corticosteroids for respiratory symptoms. * The patient's medical records must be accessible by the enrolling site over the follow-up period
Exclusion criteria
* Less than 30 days from diagnosis of a COPD exacerbation as defined as taking antibiotics and/or corticosteroids for respiratory symptoms, hospitalization, urgent care or emergency department visit for respiratory illness. * Less than 30 days from diagnosis of a HF event as defined as any cardiovascular-related (including hypervolemia) Health Care Utilizations (HCUs) for any one of the following events: * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: * Admission with secondary/tertiary diagnosis of HF * Emergency Department * Ambulance * Observation Unit * Urgent Care * HF/Cardiology Clinic * Active respiratory infection being treated with antibiotics and/or corticosteroids * Class IV heart failure * Clinical diagnosis of unstable angina, bronchiectasis, or cystic fibrosis * Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator * Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment) * Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager * Patient has an existing or planned implantation of Medtronic IPG, ICD, CRT-D or CRT-P device in the near future * Patient has an existing and active insertable cardiac monitor, regardless of manufacturer * Concurrent disease with life expectancy less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD Event | from subject randomization until 12 month follow-up | Incidence of first COPD event |
Countries
United States
Participant flow
Pre-assignment details
Though 42 subjects were enrolled, 2 subjects did not have successful Reveal LINQ insertions. Therefore, 40 subjects started the study.
Participants by arm
| Arm | Count |
|---|---|
| Full Cohort Participants had a successful Reveal LINQ insertion and investigational RAMware download. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Full Cohort |
|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Heart Rate | 80.5 bpm STANDARD_DEVIATION 15.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 40 participants |
| Respiratory rate | 18.2 breaths per minute STANDARD_DEVIATION 2.7 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 40 |
| other Total, other adverse events | 24 / 40 |
| serious Total, serious adverse events | 27 / 40 |
Outcome results
Primary
COPD Event
Incidence of first COPD event
Time frame: from subject randomization until 12 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Cohort | COPD Event | 28 Participants |