Cardiox Shunt Detection Technology Study

Stopped early · Phase 3

Conditions studied: Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT01333761

Run by

Cardiox Corporation

People needed

71

Starts

2011-04-01

Expected to finish

2012-07-01

Last updated by the study team

2013-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Heart and Vascular Center of Arizona — Phoenix, Arizona, United States
• UCLA Medical Center — Los Angeles, California, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• Swedish Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.