Clinical trial NCT04169529: Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)
Official title: Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population for the LINQ for COPD study is COPD patients who are known to have frequent exacerbations (one requiring hospitalization, ED visit, or urgent care visit, or at least two others in the past year).

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.

Eligibility criteria: 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

Primary outcomes:
measure: COPD Event
timeFrame: from subject randomization until 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Bay Area Cardiology Associates
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners Inc
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Marlton
country: United States
facility: Virtua Pulmonology Marlton
state: New Jersey
city: New York
country: United States
facility: Northwell Health Lenox Hill Hospital
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
affiliation: U.S. Department of Veterans Affairs Minneapolis Healthcare System
name: Christine Wendt, MD
role: PRINCIPAL_INVESTIGATOR
References: