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

Completed

• Conditions: Takotsubo Syndrome

• Registration Number: NCT01249599
• Lead Sponsor: University of Zurich

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 Description

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial function as flow mediated dilatation	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 Outcome Measures

Name	Time	Method
Evaluation of vascular compliance as pulse wave analysis	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

University Hospital Zurich, Division of Cardiology; 🇨🇭 Zurich, ZH, Switzerland