Syndrome XENDAUTNCT02307214
Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology
A study testing BaroReflex Sensitivity, endothelial function measurement in people with Syndrome X and Takotsubo Cardiomyopathy, run by Ospedale San Giovanni Bellinzona at 1 site in Switzerland.
Trial summary
Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Syndrome X, Takotsubo Cardiomyopathy
- What is being tested?
- BaroReflex Sensitivity, endothelial function measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2013to Apr 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with the Mayo Clinic's criteria established diagnosis of TTC at least 6 month after the acute event
- Patients with CSX defined by the presence of anginal pain, positive exercise stress testing and negative coronary angiography.
- A comparable cohort of healthy volunteers age and sex-matched with patients
Who cannot join
- Short-term life-threatening pathology (life expectancy < 6 months)
- Physically unable to participate in the study
- Compliance not guaranteed
- Pregnancy
- Conditions that make BRS and Endopat measurements impossible
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
Bellinzona, Canton Ticino, 6500
About this study
Official title: Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases
Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. However, despite significant progress, their underlying pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial dysfunction and autonomic imbalance have both been individually implied in their puzzling pathogenesis.
The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and healthy volunteers with the following primary objective: to assess the response of endothelial function (through the Endopat score) to the autonomic tone activation induced by a 10-minute stress mental test. The assessment of autonomic tone during activation through the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with endothelial function (Endopat score) will represent secondary objectives.
Our study will enroll 15 patients with TTC at least six months after the event, 15 patients with classic CSX and 15 healthy volunteers who will serve as control.
- Conditions
- Syndrome X, Takotsubo Cardiomyopathy
- Being tested
- BaroReflex Sensitivity, endothelial function measurement
- Medical subject headings
- Microvascular Angina, Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaroReflex Sensitivity, endothelial function measurementOther
Also called BaroReflex Sensitivity measurement by volume-clamp method (Finapress), Endothelial function measured by Endopat
no other
| Study group | Role | What they receive |
|---|---|---|
| Coronary X syndrome | Other | BaroReflex Sensitivity, endothelial function measurement Receives: Other: BaroReflex Sensitivity, endothelial function measurement |
| Tako-tsubo cardiomyopathy | Other | BaroReflex Sensitivity, endothelial function measurement Receives: Other: BaroReflex Sensitivity, endothelial function measurement |
| Healty Volunteers | Other | BaroReflex Sensitivity, endothelial function measurement Receives: Other: BaroReflex Sensitivity, endothelial function measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in endothelial function in response to autonomic tone (Endopat score)
Difference in endothelial function assessed by Endopat score in response to autonomic tone induced by 10-minute mental stress test between the three groups (CSX, TTC, healty volunteers)
Measured: Baseline
Secondary outcomes (3)
BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)
Changes in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers)
Measured: Baseline
BaroReflex Sensitivity and endothelial dysfunction (
Correlation with between BaroReflex Sensitivity [volume clamp method] and EndoPAT score in the three groups (CSX, TTC, healty volunteers)
Measured: Baseline
Endothelial dysfunction (Changes in Endopat score)
Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndrome XStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Giovanni Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Augusto Gallino, Ospedale San Giovanni Bellinzona
- Investigators
- Augusto Gallino, Prof MD, Principal investigator, Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, BellinzonaMattia Cattaneo, MD, Study chair, Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, BellinzonaAlessandra Pia Porretta, MD, Study chair, Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307214
- Sponsor's protocol ID
- CE 2688
- Acronym
- ENDAUT
- Status last verified
- Apr 2016
- First submitted
- 26 Nov 2014
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases
- ClinicalTrials.gov ID
- NCT02307214
- Acronym / sponsor ID
- ENDAUT / CE 2688
- Conditions
- Syndrome X, Takotsubo Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ospedale San Giovanni BellinzonaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Dec 2014 (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.
Tako-Tsubo Cardiomyopathy (TTC) and Cardiac Syndrome X (CSX) are respectively acute and chronic cardiac conditions whose clinical presentation, mimicking the onset of acute myocardial ischemia in absence of epicardial coronary disease, has progressively gained the interest of the scientific community. However, despite significant progress, their underlying pathophysiology, which seems to evoke some similarities, still remains elusive. Endothelial dysfunction and autonomic imbalance have both been individually implied in their puzzling pathogenesis.
The investigators plan to conduct our study in a cohort of TTC patients, CSX patients and healthy volunteers with the following primary objective: to assess the response of endothelial function (through the Endopat score) to the autonomic tone activation induced by a 10-minute stress mental test. The assessment of autonomic tone during activation through the evaluation of Spontaneous BaRoreflex Sensitivity (BRS) and its correlation with endothelial function (Endopat score) will represent secondary objectives.
Our study will enroll 15 patients with TTC at least six months after the event, 15 patients with classic CSX and 15 healthy volunteers who will serve as control.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary X syndrome | Other | Other: BaroReflex Sensitivity, endothelial function measurementBaroReflex Sensitivity, endothelial function measurement |
| Tako-tsubo cardiomyopathy | Other | Other: BaroReflex Sensitivity, endothelial function measurementBaroReflex Sensitivity, endothelial function measurement |
| Healty Volunteers | Other | Other: BaroReflex Sensitivity, endothelial function measurementBaroReflex Sensitivity, endothelial function measurement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with the Mayo Clinic's criteria established diagnosis of TTC at least 6 month after the acute event
- Patients with CSX defined by the presence of anginal pain, positive exercise stress testing and negative coronary angiography.
- A comparable cohort of healthy volunteers age and sex-matched with patients
Key exclusion criteria (5 listed)
- Short-term life-threatening pathology (life expectancy < 6 months)
- Physically unable to participate in the study
- Compliance not guaranteed
- Pregnancy
- Conditions that make BRS and Endopat measurements impossible
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 |
|---|---|---|
| BaroReflex Sensitivity, endothelial function measurementAlso: BaroReflex Sensitivity measurement by volume-clamp method (Finapress), Endothelial function measured by Endopatno other | Other | Coronary X syndrome, Healty Volunteers, Tako-tsubo cardiomyopathy |
Primary outcome
Difference in endothelial function in response to autonomic tone (Endopat score)
Time frame: Baseline
Difference in endothelial function assessed by Endopat score in response to autonomic tone induced by 10-minute mental stress test between the three groups (CSX, TTC, healty volunteers)
3 secondary outcomes
BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)
Time frame: Baseline
BaroReflex Sensitivity and endothelial dysfunction (
Time frame: Baseline
Endothelial dysfunction (Changes in Endopat score)
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 26 Apr 2016.
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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.
Augusto Gallino, Prof MD principal investigator
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
Mattia Cattaneo, MD study chair
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
Alessandra Pia Porretta, MD study chair
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BaroReflex Sensitivity, endothelial function measurement in people with Syndrome X and Takotsubo Cardiomyopathy, run by Ospedale San Giovanni Bellinzona 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 3 inclusion and 5 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 26 Apr 2016. 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?
Difference in endothelial function in response to autonomic tone (Endopat score) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.