Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

This study has been terminated.
(Due to difficulty in recruitment and resource restraints)
Sponsor:
Information provided by (Responsible Party):
Anand Chockalingam, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01048125
First received: January 11, 2010
Last updated: November 22, 2016
Last verified: October 2016
Results First Received: September 23, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Cardiomyopathy
Interventions: Device: Sympathetic Nerve Activity
Behavioral: Mental Stress Test (Color Word Test)
Drug: The Modified Oxford Technique for Baroreflex Sensitivity
Other: Cold Pressor Test
Device: Echocardiographic evaluation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Group Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
Control

Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation

Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity

Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word "green" is written in blue ink, they will say "blue." This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.

The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride


Participant Flow:   Overall Study
    Study Group   Control
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide 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.
Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.

Reporting Groups
  Description
Study Group Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
Control Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
Total Total of all reporting groups

Baseline Measures
   Study Group   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 
Age       
<=18 years         0 
Between 18 and 65 years         0 
>=65 years         0 
Gender       
Female         0 
Male         0 
Region of Enrollment       
United States         0 


  Outcome Measures

1.  Primary:   Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Anand Chockalingam
Organization: University of Missouri-Columbia
phone: 573/882-2296
e-mail: chockalingama@health.missouri.edu



Responsible Party: Anand Chockalingam, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01048125     History of Changes
Other Study ID Numbers: 1141858
Study First Received: January 11, 2010
Results First Received: September 23, 2016
Last Updated: November 22, 2016
Health Authority: United States: Institutional Review Board