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.

Study Overview

• Status: Completed
• Conditions: Takotsubo Syndrome
• Intervention / Treatment: Procedure: blood sample analysis

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 Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Georg Noll, Prof MD, University Hospital Zurich, Division of Cardiology

Publications and helpful links

General Publications

• Naegele M, Flammer AJ, Enseleit F, Roas S, Frank M, Hirt A, Kaiser P, Cantatore S, Templin C, Frohlich G, Romanens M, Luscher TF, Ruschitzka F, Noll G, Sudano I. Endothelial function and sympathetic nervous system activity in patients with Takotsubo syndrome. Int J Cardiol. 2016 Dec 1;224:226-230. doi: 10.1016/j.ijcard.2016.09.008. Epub 2016 Sep 12.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (ESTIMATE): November 30, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: endothelial function; arterial compliance; sympathetic nervous activity; Takotsubo Syndrome; apical balooning syndrome; stress-cardiomyopathy; platelet adhesion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Ventricular Dysfunction, Left; Ventricular Dysfunction; Syndrome; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 2010-0210/1