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Trial record 1 of 320 for:    heart disease AND stroke AND California
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Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD

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ClinicalTrials.gov Identifier: NCT02326649
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Davis, University of California, San Diego

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Congenital Heart Disease
Intervention: Device: Physioflow

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
SMIC and CMR Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging

Participant Flow:   Overall Study
    SMIC and CMR
STARTED   33 
COMPLETED   21 
NOT COMPLETED   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Diagnosis, Age, and Body Size of Subjects Overall

Baseline Measures
   Diagnosis, Age, and Body Size of Subjects 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Mean (Full Range)
 
Participants Analyzed   21 
   18 
 (7 to 30) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   21 
Female      8  38.1% 
Male      13  61.9% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Body Surface Area 
[Units: Meters squared]
Mean (Full Range)
 
Participants Analyzed   21 
   1.67 
 (0.8 to 2.2) 


  Outcome Measures

1.  Primary:   Mean Difference in Stroke Volume Between CMR and SMIC   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher Davis
Organization: UCSD
phone: 8589665855 ext 5668
e-mail: cdavis@rchsd.org



Responsible Party: Dr. Christopher Davis, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02326649     History of Changes
Other Study ID Numbers: 140550
First Submitted: December 15, 2014
First Posted: December 29, 2014
Results First Submitted: February 28, 2017
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017