NCT00659464

Brief Summary

PURPOSE OF THE STUDY This study will explore the use of multi-site NIRS monitoring during tilt table testing, combining somatic and cerebral saturations data with hemodynamic data to establish the non-invasive assessment of global cardiac output distribution trends. HYPOTHESIS / SPECIFIC AIMS Study Aims: To evaluate the utility of multi-site NIRS monitoring in the cardiovascular hemodynamic assessment of children and adolescents during tilt table testing by establishing a non-invasive method to predict cardiac output maldistribution with the use of two-site NIRS monitoring in children and adolescents with syncope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

2.8 years

First QC Date

April 10, 2008

Last Update Submit

February 9, 2012

Conditions

Keywords

Infrared SpectroscopySyncopeTilt Table Testing

Study Arms (1)

1

Children who present to the heart center exercise stress lab for investigation of syncope

Eligibility Criteria

Age7 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children ages 7 through 21 years who present to exercise stress lab for investigation of syncope.

You may qualify if:

  • Between the ages of 7 and 21 years
  • Referred to the exercise stress lab due to syncope

You may not qualify if:

  • Under 7 or over 21 years of age
  • Referred to the exercise stress lab for anything other than syncope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Rao RP, Danduran MJ, Dixon JE, Frommelt PC, Berger S, Zangwill SD. Near infrared spectroscopy: guided tilt table testing for syncope. Pediatr Cardiol. 2010 Jul;31(5):674-9. doi: 10.1007/s00246-010-9683-z. Epub 2010 Mar 4.

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rohit Rao, MD

    Medical College of Wisconsin/Children's Hospital of Wisconsin

    PRINCIPAL INVESTIGATOR
  • John Hambrook, MD

    Medical College of Wisconsin/Children's Hospital of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Pediatrics Cardiology

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 16, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations