Clinical trial NCT01333761: Cardiox Shunt Detection Technology Study
Official title: FDS-0004 Cardiox Shunt Detection Technology Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Patent Foramen Ovale
Keywords: right to left cardiac shunt finding
Lead sponsor: Cardiox Corporation
Sponsor class: INDUSTRY
First posted: 2011-04-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green (ICG) dye in the blood and is being investigated to establish its efficacy in detecting the presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against transesophageal echocardiography (TEE) for sensitivity and specificity, as well as transcranial doppler (TCD) for positive percent agreement and negative percent agreement.


Eligibility criteria: Inclusion Criteria:

* Eighteen (18) years of age or older
* Informed consent documentation understood and signed
* Planned or completed TEE study within the last 12 months

Exclusion Criteria:

* Subjects with a known allergy or sensitivity to Indocyanine Green Dye (ICG) or to Iodide Contrast Dye or Iodides
* Pregnant women or nursing mothers
* Subject unable or unwilling to understand and sign the informed consent
* Subject scheduled for radioactive iodine uptake test (Thyroid test) within 7 days of post screening
* Subjects that have poor renal function such as subjects on dialysis, subjects with a recent history of creatinine \> 2.0 or subjects currently being followed by a nephrologist

Primary outcomes:
measure: To evaluate the Cardiox FDS system using TCD as a non-reference standard for positive percent agreement for accurately detecting a RTLS and negative percent agreement for accurately detecting the absence of RTLS
timeFrame: 1 day
measure: To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS
timeFrame: 1 day
Secondary outcomes:
measure: To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt
timeFrame: 1 day
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Heart and Vascular Center of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Seattle
country: United States
facility: Swedish Hospital
state: Washington
Study officials:
References:
citation: Karttunen V, Ventila M, Hillbom M, Salonen O, Haapaniemi H, Kaste M. Dye dilution and oximetry for detection of patent foramen ovale. Acta Neurol Scand. 1998 Apr;97(4):231-6. doi: 10.1111/j.1600-0404.1998.tb00643.x.
citation: Spencer MP, Moehring MA, Jesurum J, Gray WA, Olsen JV, Reisman M. Power m-mode transcranial Doppler for diagnosis of patent foramen ovale and assessing transcatheter closure. J Neuroimaging. 2004 Oct;14(4):342-9. doi: 10.1177/1051228404268743.