Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome

Study Overview
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Brief Summary
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The aim of this prospective single-center study is to evaluate endothelial function, arterial compliance, sympathetic nervous activity at rest and after mental and physical stress, carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion in patients with apical ballooning syndrome and age-matched controls.

Detailed Description
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The aim of this prospective single-center study is to evaluate endothelial function, arterial compliance, sympathetic nervous activity at rest and after mental and physical stress, carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion in patients with Takotsubo Syndrome (apical ballooning syndrome/broken heart syndrome) and age-matched controls.

Official Title
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Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome

Conditions
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Takotsubo Syndrome

Intervention / Treatment
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* Procedure: blood sample analysis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: We plan to include male or female subjects, age 18-80 with a diagnosis of Takotsubo Syndrome (according to standard clinical criteria[Strony, J., et al., Analysis of shear stress and hemodynamic factors in a model of coronary artery stenosis and thrombosis. Am J Physiol, 1993. 265(5 Pt 2): p. H1787-96.]) in the last 10 years. Moreover, patients matched to the Takotsubo patients for age and cardiovascular risk factors will be included in the control group. All patients will signed an written informed consent Exclusion criteria: Long acting nitrates, or PDE-5-Hemmer Alcohol or drug abuse, Malignancy (unless healed or remission > 5 years) Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn) Pulmonary Hypertension Participation in another study within the last month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood sample analysis|The aim of this prospective single-center study is to evaluate endothelial function, vascular compliance, oxidative stress parameters, quality of life and platelet adhesion in patients with apical ballooning syndrome and age-matched controls.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function as flow mediated dilatation | Evaluation of endothelial function as flow mediated dilation in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of vascular compliance as pulse wave analysis | Comparison of vascular compliance as pulse wave analysis in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Evaluation of pulse wave velocity | Comparison of pulse wave velocity in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Evaluation of carotid atherosclerosis as intima-media-thickness and total plaque area | Comparison of carotid atherosclerosis as intima-media-thickness and total plaque area in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Measurement of sympathetic nervous activity | Comparison of sympathetic nervous activity at rest, after cold pressor test and after mental stress tests in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Evaluation of platelet adhesion | Comparison of shear-stress dependent platelet adhesion by the Cone and Platelet Analyzer in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Evaluation of oxidative stress parameters | Comparison of oxidative stress parameters in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Evaluation of tissue factor plasma level | Comparison of tissue factor plasma level in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors | baseline | 
| Assessment of quality of life and perceived stress, anxiety and depression | Comparison of quality of life and perceived stress, anxiety and depression in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors Quality of life will be assessed using the German version of the European Quality of Life Questionnaire EQ-5D (www.euroqol.org). Perceived stress, anxiety and depression will be assessed by the Hospital Anxiety and Depression Scale. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Takotsubo Syndrome, apical balooning syndrome, stress-cardiomyopathy, endothelial function, sympathetic nervous activity, platelet adhesion, arterial compliance