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

December 10, 2012 updated by: University of Zurich
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0210/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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