Takotsubo SyndromeNCT01249599
Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome
An observational study of Takotsubo Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Takotsubo Syndrome
- What is being tested?
- blood sample analysis
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Cardiology
Zurich, Canton of Zurich, 8091
About this study
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.
Read the 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.
- Conditions
- Takotsubo Syndrome
- Being tested
- blood sample analysis
- Keywords
- Takotsubo Syndrome, apical balooning syndrome, stress-cardiomyopathy, endothelial function, sympathetic nervous activity, platelet adhesion, arterial compliance
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample analysisProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (8)
Evaluation of vascular compliance as pulse wave analysis
Comparison of vascular compliance as pulse wave analysis in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors
Measured: baseline
Evaluation of pulse wave velocity
Comparison of pulse wave velocity in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors
Measured: baseline
Evaluation of carotid atherosclerosis as intima-media-thickness and total plaque area
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
Measured: baseline
Measurement of sympathetic nervous activity
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
Measured: baseline
Evaluation of platelet adhesion
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
Measured: baseline
Evaluation of oxidative stress parameters
Comparison of oxidative stress parameters in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors
Measured: baseline
Evaluation of tissue factor plasma level
Comparison of tissue factor plasma level in patients with apical ballooning syndrome and controls matched for age and cardiovascular risk factors
Measured: baseline
Assessment of quality of life and perceived stress, anxiety and depression
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takotsubo SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Noll, Prof MD, Principal investigator, University Hospital Zurich, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249599
- Sponsor's protocol ID
- 2010-0210/1
- Status last verified
- Dec 2012
- First submitted
- 22 Nov 2010
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27661411
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome
- ClinicalTrials.gov ID
- NCT01249599
- Acronym / sponsor ID
- 2010-0210/1
- Conditions
- Takotsubo Syndrome
- Keywords
- Takotsubo Syndrome, apical balooning syndrome, stress-cardiomyopathy, endothelial function, sympathetic nervous activity, platelet adhesion, arterial compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample analysisThe 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. | Procedure or surgery | – |
Primary outcome
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
8 secondary outcomes
Evaluation of vascular compliance as pulse wave analysis
Time frame: baseline
Evaluation of pulse wave velocity
Time frame: baseline
Evaluation of carotid atherosclerosis as intima-media-thickness and total plaque area
Time frame: baseline
Measurement of sympathetic nervous activity
Time frame: baseline
Evaluation of platelet adhesion
Time frame: baseline
Evaluation of oxidative stress parameters
Time frame: baseline
Evaluation of tissue factor plasma level
Time frame: baseline
Assessment of quality of life and perceived stress, anxiety and depression
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Derived from this study: PubMed 27661411Naegele 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.
Related trials for Takotsubo Syndrome
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Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
Chronic Obstructive Pulmonary Disease, Takotsubo Cardiomyopathy
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Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Takotsubo Cardiomyopathy, Myocardial Infarction
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Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
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The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study
Takotsubo Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Noll, Prof MD principal investigator
University Hospital Zurich, Division of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Syndrome, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function as flow mediated dilatation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01249599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.