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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01249599
Enrollment
44
Registered
2010-11-30
Start date
2010-11-30
Completion date
2012-10-31
Last updated
2012-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Syndrome

Keywords

Takotsubo Syndrome, apical balooning syndrome, stress-cardiomyopathy, endothelial function, sympathetic nervous activity, platelet adhesion, arterial compliance

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.

Interventions

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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial function as flow mediated dilatationbaselineEvaluation of endothelial function as flow mediated dilation in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors

Secondary

MeasureTime frameDescription
Evaluation of pulse wave velocitybaselineComparison 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 areabaselineComparison 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 activitybaselineComparison 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 vascular compliance as pulse wave analysisbaselineComparison of vascular compliance as pulse wave analysis in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors
Evaluation of oxidative stress parametersbaselineComparison of oxidative stress parameters in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors
Evaluation of tissue factor plasma levelbaselineComparison 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 depressionbaselineComparison 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.
Evaluation of platelet adhesionbaselineComparison 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026