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

Study Overview
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Brief Summary
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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.

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

Conditions
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Syndrome X, Takotsubo Cardiomyopathy

Intervention / Treatment
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* Other: BaroReflex Sensitivity, endothelial function measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coronary X syndrome<br>BaroReflex Sensitivity, endothelial function measurement | Other: BaroReflex Sensitivity, endothelial function measurement<br>* no other<br>* Other names: Endothelial function measured by Endopat;|
| Other: Tako-tsubo cardiomyopathy<br>BaroReflex Sensitivity, endothelial function measurement | Other: BaroReflex Sensitivity, endothelial function measurement<br>* no other<br>* Other names: Endothelial function measured by Endopat;|
| Other: Healty Volunteers<br>BaroReflex Sensitivity, endothelial function measurement | Other: BaroReflex Sensitivity, endothelial function measurement<br>* no other<br>* Other names: Endothelial function measured by Endopat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BaroReflex Sensitivity (Sensitivity measurement by volume-clamp method (Finapress) | Changes in BaroReflex Sensitivity from baseline in three three groups (CSX, TTC, healty volunteers) | 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) | Baseline | 
| Endothelial dysfunction (Changes in Endopat score) | Changes in Endopat score from baseline in three three groups (CSX, TTC, healty volunteers) | Baseline |