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

NCT01249599 | Completed DMC

• 1 other identifier: 2010-0210/1
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Evaluation of vascular compliance as pulse wave analysis

  baseline

• Evaluation of pulse wave velocity

  baseline

• Evaluation of carotid atherosclerosis as intima-media-thickness and total plaque area

  baseline

• Measurement of sympathetic nervous activity

  baseline

• Evaluation of platelet adhesion

  baseline

Interventions

blood sample analysis PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 27661411 DERIVED

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Georg Noll, Prof MD

  University Hospital Zurich, Division of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 30, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

CH (1)