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Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology

Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology of Two Orphan Cardiac Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02307214
Acronym
ENDAUT
Enrollment
39
Registered
2014-12-04
Start date
2013-10-31
Completion date
2016-04-30
Last updated
2016-04-26

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

Conditions

Syndrome X, Takotsubo Cardiomyopathy

Brief 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. 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.

Interventions

OTHERBaroReflex Sensitivity, endothelial function measurement

no other

Sponsors

Ospedale San Giovanni Bellinzona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Difference in endothelial function in response to autonomic tone (Endopat score)BaselineDifference 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)

Secondary

MeasureTime frameDescription
BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress)BaselineChanges in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers)
BaroReflex Sensitivity and endothelial dysfunction (BaselineCorrelation with between BaroReflex Sensitivity \[volume clamp method\] and EndoPAT score in the three groups (CSX, TTC, healty volunteers)
Endothelial dysfunction (Changes in Endopat score)BaselineChanges in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026