Heartsbreath Test for Heart Transplant Rejection
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validation of Heartsbreath Test for Heart Transplant Rejection|
- To measure the sensitivity and specificity of the breath test as compared to the primary right ventricular endomyocardial biopsy for the development of an intrinsically safe, painless, and non-invasive detection technique. [ Time Frame: 60 days after completion ] [ Designated as safety issue: No ]The current "gold standard" for heart transplant rejection diagnosis is a series of endomyocardial biopsies during the first twelve months after operation. This procedure is invasive, painful, and potentially hazardous. The Heartsbreath test is an intrinsically safe, painless, and non-invasive breath test for heart transplant rejection that employs volatile biomarkers of oxidative stress. The Food & Drug Administration (FDA) approved the Heartsbreath test for clinical use with a Humanitarian Device Exemption (HDE).
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Subjects will comprise of patients who are the recipients of a heart transplant within the previous 12 months and are scheduled for a routine endomyocardial biopsy.
Subjects will provide breath samples for the Heartsbreath test using the BreathScanner 1.0. Optionally subjects will provide breath samples using the BreathLink point of care system.
Device: BreathScanner 1.0
For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.Device: BreathLink
The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397812
|United States, California|
|Cedars-Sinai Medical Center|
|Beverly Hills, California, United States, 90211|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305-5406|
|United States, New Jersey|
|Newark Beth Israel Medical Center|
|Newark, New Jersey, United States, 07112|
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Hahnemann University Hospital and the Drexel University College of Medicine|
|Philadelphia, Pennsylvania, United States, 19102|
|Principal Investigator:||Michael Phillips, MD, FACP||Menssana Research, Inc.|