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Completed

NCT Number: NCT01249599

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

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.

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Key information

Conditions

Takotsubo Syndrome Cardiomyopathies Cardiovascular Diseases Heart Diseases Takotsubo Cardiomyopathy Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample analysis

Procedure

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.

Primary outcomes

  1. Endothelial function as flow mediated dilatation

    Time frame: baseline

    Evaluation of endothelial function as flow mediated dilation in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors

Secondary outcomes

  1. Evaluation of vascular compliance as pulse wave analysis

    Time frame: baseline

    Comparison of vascular compliance as pulse wave analysis in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors

  2. Evaluation of pulse wave velocity

    Time frame: baseline

    Comparison of pulse wave velocity in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors

  3. Evaluation of carotid atherosclerosis as intima-media-thickness and total plaque area

    Time frame: baseline

    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

  4. Measurement of sympathetic nervous activity

    Time frame: baseline

    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

  5. Evaluation of platelet adhesion

    Time frame: baseline

    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

  6. Evaluation of oxidative stress parameters

    Time frame: baseline

    Comparison of oxidative stress parameters in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors

  7. Evaluation of tissue factor plasma level

    Time frame: baseline

    Comparison of tissue factor plasma level in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors

  8. Assessment of quality of life and perceived stress, anxiety and depression

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2010
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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