Clinical trial NCT01249599: Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome
Official title: Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takotsubo Syndrome
Keywords: Takotsubo Syndrome
apical balooning syndrome
stress-cardiomyopathy
endothelial function
sympathetic nervous activity
platelet adhesion
arterial compliance
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Endothelial function as flow mediated dilatation
timeFrame: baseline
Secondary outcomes:
measure: Evaluation of vascular compliance as pulse wave analysis
timeFrame: baseline
measure: Evaluation of pulse wave velocity
timeFrame: baseline
measure: Evaluation of carotid atherosclerosis as intima-media-thickness and total plaque area
timeFrame: baseline
measure: Measurement of sympathetic nervous activity
timeFrame: baseline
measure: Evaluation of platelet adhesion
timeFrame: baseline
measure: Evaluation of oxidative stress parameters
timeFrame: baseline
measure: Evaluation of tissue factor plasma level
timeFrame: baseline
measure: Assessment of quality of life and perceived stress, anxiety and depression
timeFrame: baseline
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Cardiology
name: Georg Noll, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.