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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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 Summary: 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.
Sponsor: University of Zurich

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.


Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: November 22, 2010
Date Started: November 2010
Date Completion:
Last Updated: December 10, 2012
Last Verified: December 2012