Precision of IMED-4 Lung Fluid Measurements

NCT02187770 | Completed DMC

• 1 other identifier: CP-000040
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Dyspnea; Acute Heart Failure Syndrome; Pulmonary Congestion

Outcome Measures

Primary Outcomes (1)

• Lung Fluid Status

  IMED 4 is a new device to measure lung fluid status by assessing how wet or dry the lungs are

  Up to 1 year

Interventions

IMED-4 DEVICE

Non invasive recording electrode used to assess lung fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• i. Presence of an S3 heart sound ii. Lung rales/crackles/crepitations
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Intersection Medical, Inc.: lead

Study Sites (3)

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 11, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (3)