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Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

Primary Purpose

Cardiomyopathy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sympathetic Nerve Activity
Mental Stress Test (Color Word Test)
The Modified Oxford Technique for Baroreflex Sensitivity
Cold Pressor Test
Echocardiographic evaluation
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiomyopathy focused on measuring Stress-induced cardiomyopathy, Takotsubo cardiomyopathy

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of stress cardiomyopathy in the past

Exclusion Criteria:

  • Coronary artery disease (CAD), primary coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Cardiac dysfunction
  • Heart failure
  • Significant arrhythmias
  • Severe chronic obstructive pulmonary disease (COPD)
  • Diabetic neuropathy
  • Pregnancy

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control

Arm 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

Outcomes

Primary Outcome Measures

Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2010
Last Updated
November 22, 2016
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01048125
Brief Title
Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy
Official Title
Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to difficulty in recruitment and resource restraints
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial dysfunction predominantly affecting the apical and mid left ventricular segments. In this institution over the last two to three years the investigators have identified more than a dozen patients with stress cardiomyopathy. The investigators' overarching goal is to characterize these individuals with the hope of identifying risk factors and developing strategies to prevent the occurrence of SC in situations where the likelihood in susceptible individuals may be high.
Detailed Description
Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial dysfunction predominantly affecting the apical and mid left ventricular segments. This was originally described in Japan but is increasingly recognized all over the world especially in older women. There is evidence to support that excess sympathetic activation and catecholamine surges are potential mechanisms that cause this temporary myocardial 'stunning'. The amount of catecholamines in circulation of patients with SC was 2 to 3-fold higher when compared to subjects with acute myocardial infarction related equivalent cardiac dysfunction [Wittstein, et al. NEJM, 2005]. In this institution over the last two to three years the investigators have identified more than a dozen patients with stress cardiomyopathy. This diagnosis has been confirmed by echocardiographic documentation of normalization of left ventricular function over a course of few days to weeks. The investigators' overarching goal is to further characterize these individuals with the hope of identifying risk factors and developing strategies to prevent the occurrence of SC in situations where the likelihood in susceptible individuals may be high.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy
Keywords
Stress-induced cardiomyopathy, Takotsubo cardiomyopathy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Sympathetic Nerve Activity
Intervention Description
Resting Sympathetic Nerve Activity
Intervention Type
Behavioral
Intervention Name(s)
Mental Stress Test (Color Word Test)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
The Modified Oxford Technique for Baroreflex Sensitivity
Other Intervention Name(s)
Sodium Nitroprusside, Phenylephrine hydrochloride
Intervention Description
Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride (150 µg). Infusion of nitroprusside will decrease blood pressure approximately 10-15 mmHg below baseline values. Subsequent phenylephrine infusion will increase blood pressure approximately 10-15 mmHg above baseline values. Nitroprusside and phenylephrine have been used extensively to assess baroreflex sensitivity in healthy as well as heart failure populations. Additionally, the dosages being used have been shown to minimize the risk of excessive decreases or increases in blood pressure.
Intervention Type
Other
Intervention Name(s)
Cold Pressor Test
Intervention Description
The subject will be asked to place their hand in ice water for 2 minutes. This procedure will be used to cause transient changes in sympathetic nerve activity, heart rate and blood pressure.
Intervention Type
Device
Intervention Name(s)
Echocardiographic evaluation
Intervention Description
Transthoracic echocardiography with 2D, color and pulse Doppler will be employed in all of our subjects. Baseline left ventricular function, systolic as well as diastolic, will be quantified.
Primary Outcome Measure Information:
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of stress cardiomyopathy in the past Exclusion Criteria: Coronary artery disease (CAD), primary coronary intervention (PCI) or coronary artery bypass graft (CABG) Cardiac dysfunction Heart failure Significant arrhythmias Severe chronic obstructive pulmonary disease (COPD) Diabetic neuropathy Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Chockalingam, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

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Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

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