DyspneaNCT02187770
Precision of IMED-4 Lung Fluid Measurements
An observational study of Dyspnea and Acute Heart Failure Syndrome, run by Intersection Medical, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine if IMED-4 recordings have sufficient precision to detect a clinically significant change in lung fluid status in acute heart failure syndrome with pulmonary congestion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Acute Heart Failure Syndrome, Pulmonary Congestion
- What is being tested?
- IMED-4
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted for inpatient management with acute heart failure syndrome with pulmonary congestion 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
- Diagnosed with acute heart failure syndrome with pulmonary congestion defined by a Brain natriuretic peptide (BNP) >350 pg/mL or N-terminal pro-brain natriuretic peptide (NT-pro BNP) >1500 pg/mL and any one of the following:
- PCWP >25mmHg
- Dyspnea at rest in a recumbent sitting position (30 to 45 degrees), which has worsened within the past week
- Radiological evidence of CHF on a chest X-ray
- Physical exam as evidence for pulmonary congestion:
- Presence of an S3 heart sound ii. Lung rales/crackles/crepitations
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- Age greater than or equal to (≥) 18
- Ability to reliably carry out self-assessment of symptoms
- Willingness, ability and commitment to participate in index and follow-up IMED-4 recordings
Who cannot join
- Known active myocarditis, obstructive hypertrophic cardiomyopathy, constrictive pericarditis, uncorrected clinically significant primary valvular disease
- Clinical diagnosis of acute coronary syndrome meeting any 2 of the following 3 criteria:
- Prolonged chest pain at rest, or an accelerated pattern of angina
- Electrocardiogram changes indicative of ischemia or myocardial injury
- Serum troponin >3 times upper limit of lab normal
- Clinically-suspected acute mechanical cause of ADHF (e.g., papillary muscular rupture); the diagnosis need not be confirmed by imaging or cardiac catheterization
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- Estimated Glomerular Filtration Rate: eGFR <30mL/min/1.73m
- Known vasculitis, active infective endocarditis, or suspected infections including pneumonia, acute hepatitis, systemic inflammatory response syndrome, or sepsis
- Body temperature ≥38°C just prior to enrollment
- Acute or chronic respiratory disorder (e.g. severe chronic obstructive pulmonary disease (COPD)) or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements
- Total Albumin <2.5 g/dL
- Patients requiring mechanical circulatory support
- Pregnancy or lactation
- Patients who have tattoos and/or non-intact skin directly under the electrode sensor position
- Patients who have had past allergic reactions to medical grade adhesives
- Patients who have had a lung lobectomy
- Patients who decline to have their backs photographed with the IMED-4 device in position
- 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 expectance, etc.)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mass General Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
About this study
The purpose of this study is to determine if IMED-4 recordings have sufficient precision to detect a clinically significant change in lung fluid status in acute heart failure syndrome with pulmonary congestion.
Read the detailed description
The study will evaluate if the IMED-4 system has the precision to detect a clinically significant change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. Changes in lung fluid in acute heart failure syndrome are difficult to diagnose and evaluate.
- Conditions
- Dyspnea, Acute Heart Failure Syndrome, Pulmonary Congestion
- Being tested
- IMED-4
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMED-4Device
Non invasive recording electrode used to assess lung fluid
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Fluid Status
IMED 4 is a new device to measure 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 Jul 2014 (estimated)
- Study startJul 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 DyspneaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 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
- NCT02187770
- Sponsor's protocol ID
- CP-000040
- Status last verified
- Oct 2015
- First submitted
- 7 Jul 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- Precision of IMED-4 Lung Fluid Measurements
- ClinicalTrials.gov ID
- NCT02187770
- Acronym / sponsor ID
- CP-000040
- Conditions
- Dyspnea, Acute Heart Failure Syndrome, Pulmonary Congestion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Intersection Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Jul 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 if IMED-4 recordings have sufficient precision to detect a clinically significant change in lung fluid status in acute heart failure syndrome with pulmonary congestion.
Detailed description
The study will evaluate if the IMED-4 system has the precision to detect a clinically significant change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. Changes in lung fluid in acute heart failure syndrome are difficult to diagnose and evaluate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted for inpatient management with acute heart failure syndrome with pulmonary congestion are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.
Key inclusion criteria (9 listed)
- Diagnosed with acute heart failure syndrome with pulmonary congestion defined by a Brain natriuretic peptide (BNP) >350 pg/mL or N-terminal pro-brain natriuretic peptide (NT-pro BNP) >1500 pg/mL and any one of the following:
- Age greater than or equal to (≥) 18
- Ability to reliably carry out self-assessment of symptoms
- Willingness, ability and commitment to participate in index and follow-up IMED-4 recordings
Key exclusion criteria (18 listed)
- Known active myocarditis, obstructive hypertrophic cardiomyopathy, constrictive pericarditis, uncorrected clinically significant primary valvular disease
- Clinical diagnosis of acute coronary syndrome meeting any 2 of the following 3 criteria:
- Clinically-suspected acute mechanical cause of ADHF (e.g., papillary muscular rupture); the diagnosis need not be confirmed by imaging or cardiac catheterization
- Estimated Glomerular Filtration Rate: eGFR <30mL/min/1.73m
- Known vasculitis, active infective endocarditis, or suspected infections including pneumonia, acute hepatitis, systemic inflammatory response syndrome, or sepsis
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 |
|---|---|---|
| IMED-4Non invasive recording electrode used to assess lung fluid | Device | – |
Primary outcome
Lung Fluid Status
Time frame: Up to 1 year
IMED 4 is a new device to measure 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.
3 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 3 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 9 inclusion and 18 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 3 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.