Dyspnea,FLOODNCT02111525
Fluid Status of Outpatients With Dyspnea
An observational study of Dyspnea, and Acute Heart Failure Syndrome, run by Intersection Medical, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Dyspnea,, Acute Heart Failure Syndrome, Pulmonary Congestion
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who present with shortness of breath to an emergency department or urgent care facility are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.
Who may be able to join
- Shortness of breath as the most prominent presenting symptom
- Age greater ≥ 45
- Willingness, ability, and commitment to participate in the study
Who cannot join
- Patients with any active implantable medical device
- Patients who are pregnant or lactating
- Patients who have tattoos and or non-intact skin directly under the electrode position
- Patients who have had past allergic reactions to medical grade adhesives
- Patients that are dialysis dependent
- Patients who have had a lung lobectomy
Show all 11Show fewer
- Patients in whom the shortness of breath presentation is due to obvious non HF cause such as acute chest trauma
- Patients who have received nitrates (sub-lingual, topical or IV), diuretics or vasopressors ≥ 1 hour prior to IMED-4 Recording
- Patients who decline to have their backs photographed with the IMED-4 device in position
- Patients who are receiving invasive or non-invasive positive airway pressure (PAP) ventilation prior to or following presentation to the ED (Self presentation or admission via EMS).
- Severe co-morbidity or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, incarceration, shortened life expectancy, etc.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wayne State University Hospital
Detroit, Michigan, 48201
Vanderbilt University
Nashville, Tennessee, 37235
About this study
The purpose of this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath.
- Conditions
- Dyspnea,, Acute Heart Failure Syndrome, Pulmonary Congestion
- Medical subject headings
- Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Fluid Status
The IMED 4 is a new device designed to measure the lung fluid status by assessing how wet or dry the lungs are
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspnea,Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersection Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111525
- Sponsor's protocol ID
- CP-000030
- Acronym
- FLOOD
- Status last verified
- Oct 2015
- First submitted
- 8 Apr 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Status of Outpatients With Dyspnea
- ClinicalTrials.gov ID
- NCT02111525
- Acronym / sponsor ID
- FLOOD / CP-000030
- Conditions
- Dyspnea,, Acute Heart Failure Syndrome, Pulmonary Congestion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Intersection Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
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 this study is to determine the distribution of lung fluid status as reported by the IMED-4 system in patients presenting to the emergency department or urgent care facility with shortness of breath.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present with shortness of breath to an emergency department or urgent care facility are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Shortness of breath as the most prominent presenting symptom
- Age greater ≥ 45
- Willingness, ability, and commitment to participate in the study
Key exclusion criteria (11 listed)
- Patients with any active implantable medical device
- Patients who are pregnant or lactating
- Patients who have tattoos and or non-intact skin directly under the electrode position
- Patients who have had past allergic reactions to medical grade adhesives
- Patients that are dialysis dependent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung Fluid Status
Time frame: Up to 1 year
The IMED 4 is a new device designed to measure the lung fluid status by assessing how wet or dry the lungs are
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea, and Acute Heart Failure Syndrome, run by Intersection Medical, Inc. at 2 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 3 inclusion and 11 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lung Fluid Status (time frame: Up to 1 year). 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 14 Oct 2015.