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

Takotsubo Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249599
• Other study ID #: 2010-0210/1
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: December 10, 2012
• Start date: November 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Syndrome
• Takotsubo Cardiomyopathy
• Takotsubo Syndrome

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Cardiology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No