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Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01048125
Recruitment Status : Terminated (Due to difficulty in recruitment and resource restraints)
First Posted : January 13, 2010
Results First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Anand Chockalingam, University of Missouri-Columbia

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 2
Recruitment Details 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  
Arm/Group Title Study Group Control
Hide Arm/Group Description 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 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

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Study Group Control Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years 0
Between 18 and 65 years 0
>=65 years 0
Gender  
Number Analyzed 0 participants 0 participants 0 participants
Female 0
Male 0
Region of Enrollment  
United States Number Analyzed 0 participants 0 participants 0 participants
0
1.Primary Outcome
Title Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.
Arm/Group Title Study Group Control
Hide Arm/Group Description:
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 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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group Control
Hide Arm/Group Description 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 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
All-Cause Mortality
Study Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Study Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
2 participants were consented, but due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anand Chockalingam
Organization: University of Missouri-Columbia
Phone: 573/882-2296
EMail: chockalingama@health.missouri.edu
Layout table for additonal information
Responsible Party: Anand Chockalingam, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01048125     History of Changes
Other Study ID Numbers: 1141858
First Submitted: January 11, 2010
First Posted: January 13, 2010
Results First Submitted: September 23, 2016
Results First Posted: November 23, 2016
Last Update Posted: November 23, 2016