ClinicalTrials.Veeva

Menu

Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

University of Missouri (MU) logo

University of Missouri (MU)

Status

Terminated

Conditions

Cardiomyopathy

Treatments

Device: Echocardiographic evaluation
Other: Cold Pressor Test
Device: Sympathetic Nerve Activity
Drug: The Modified Oxford Technique for Baroreflex Sensitivity
Behavioral: Mental Stress Test (Color Word Test)

Study type

Interventional

Funder types

Other

Identifiers

NCT01048125
1141858

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

21 to 90 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Study group
Experimental 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
Treatment:
Other: Cold Pressor Test
Device: Echocardiographic evaluation
Drug: The Modified Oxford Technique for Baroreflex Sensitivity
Behavioral: Mental Stress Test (Color Word Test)
Device: Sympathetic Nerve Activity
Control
Active Comparator group
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
Treatment:
Other: Cold Pressor Test
Device: Echocardiographic evaluation
Drug: The Modified Oxford Technique for Baroreflex Sensitivity
Behavioral: Mental Stress Test (Color Word Test)
Device: Sympathetic Nerve Activity

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems