NCT01333761

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

March 31, 2011

Last Update Submit

January 8, 2013

Conditions

Patent Foramen Ovale

Keywords

right to left cardiac shunt finding

Outcome Measures

Primary Outcomes (2)

  • 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

    1 day

  • To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS

    1 day

Secondary Outcomes (1)

  • To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt

    1 day

Study Arms (1)

TCD/Cardiox FDS/TEE testing

EXPERIMENTAL

All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.

Device: Cardiox FDS

Interventions

Cardiox FDSDEVICE

The Cardiox Shunt Detection system consists of a sensor placed in contact with the outer ear, similar to a finger probe used to detect oxygen levels in blood. Through an intravenous line, ICG (indocyanine green) at a dosage of 10 mg (2 mL of 5 mg/mL ICG solution) per test, is administered into the right or left antecubital fossa. The presence of ICG in the veins within the outer ear are detected, and the results are displayed on a monitor. All patients will also be evaluated with TCD and TEE for the presence of RTLS.

TCD/Cardiox FDS/TEE testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama, Birmingham

Birmingham, Alabama, 35249, United States

Location

Heart and Vascular Center of Arizona

Phoenix, Arizona, 85006, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Swedish Hospital

Seattle, Washington, 98122, United States

Location

Related Publications (2)

  • 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.

    PMID: 9576637BACKGROUND

  • 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.

    PMID: 15358955BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 12, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

US(7)