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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01249599
First received: November 22, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Takotsubo Syndrome
 Procedure: blood sample analysis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Endothelial function as flow mediated dilatation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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:
  • Evaluation of vascular compliance as pulse wave analysis [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249599

Locations
Switzerland
University Hospital Zurich, Division of Cardiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Georg Noll, Prof MD University Hospital Zurich, Division of Cardiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01249599     History of Changes
Other Study ID Numbers: 2010-0210/1
Study First Received: November 22, 2010
Last Updated: December 10, 2012
Health Authority: Switzerland: Ethical Committee

Keywords provided by University of Zurich:
Takotsubo Syndrome
apical balooning syndrome
stress-cardiomyopathy
endothelial function
 sympathetic nervous activity
platelet adhesion
arterial compliance

Additional relevant MeSH terms:
Takotsubo Cardiomyopathy
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013