Chronic Obstructive Pulmonary Disease (COPD)NCT04169529
Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Reveal LINQ
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Aug 2020to 27 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Bay Area Cardiology Associates
Brandon, Florida, 33511
The Ohio State University
Columbus, Ohio, 43210
Baptist Medical Center
Jacksonville, Florida, 32207
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Clinical Site Partners Inc
Leesburg, Florida, 34748
Virtua Pulmonology Marlton
Marlton, New Jersey, 08053
Northwell Health Lenox Hill Hospital
New York, New York, 10075
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Memorial Health University Medical Center
Savannah, Georgia, 31404
About this study
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.
Read the 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.
- Being tested
- Reveal LINQ
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQDevice
Insertion of Reveal LINQ device to characterize collected data from patients with COPD.
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Event
Incidence of first COPD event
Measured: from subject randomization until 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start25 Aug 2020
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Wendt, MD, Principal investigator, U.S. Department of Veterans Affairs Minneapolis Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169529
- Sponsor's protocol ID
- MDT19019
- Status last verified
- Oct 2024
- First submitted
- 18 Nov 2019
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reveal LINQ for Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04169529
- Acronym / sponsor ID
- MDT19019
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 26 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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:
- Active respiratory infection being treated with antibiotics and/or corticosteroids
- Class IV heart failure
- Clinical diagnosis of unstable angina, bronchiectasis, or cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reveal LINQInsertion of Reveal LINQ device to characterize collected data from patients with COPD. | Device | – |
Primary outcome
COPD Event
Time frame: from subject randomization until 12 month follow-up
Incidence of first COPD event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Wendt, MD principal investigator
U.S. Department of Veterans Affairs Minneapolis Healthcare System
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Medtronic Cardiac Rhythm and Heart Failure at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Event (time frame: from subject randomization until 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.