Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X:

Study Overview
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Brief Summary
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The Tako-Tsubo Cardiomyopathy (TTC) and the Cardiac Syndrome X (CSX) are respectively acute and chronic heart diseases, which mimic myocardial infarction and stable angina pectoris without alterations of large coronary vessels. The causes and the most appropriate and best treatment for these diseases have not been yet clarified, but there are indications, that mental and psychosocial aspects may also contribute to these two diseases. So far, there is no study, which has comprehensively evaluated the interactions between mind and heart in these two conditions. The purpose of this study is to search for possible differences in mental activity, response to stressful events and function of specific areas of the brain deeply involved in relation between mind and heart. 45 subjects will be recruited and divided equally into: patients with CSX, patients with TTC (at least 6 months ago) and patients with previous acute myocardial infarction (at least 6 months ago). All participants will undergo a clinical interview and several questionnaires that assess various mental functions, the stress response and the quality of life. In addition, in a separate visit the participants will undergo a Magnetic Resonance Imaging without contrast medium that helps to assess function of specific areas of the brain.

Official Title
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Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: a Study on the Brain-heart Interactions in Two Orphan Cardiac Diseases.

Conditions
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Takotsubo Cardiomyopathy, Cardiac X Syndrome, Acute Myocardial Infarction

Intervention / Treatment
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* Other: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)
* Other: Million Clinical Multiaxial Inventory 3 (MCMI-III)
* Other: State-Trait Anxiety Inventory form Y (STAI-Y)
* Other: SF-36 Health-Related Quality of Life
* Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group A. 15 patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza et al. Group B. 15 patients with Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least 6 months after being hospitalized or diagnosed with TTC. Group C (control group). 15 prospectively enrolled patients with previous Type 1, 4a, 4b myocardial infarction (ST-segment elevation acute myocardial infarction [STEMI] and Non ST-segment elevation acute myocardial infarction [NSTEMI] acute coronary syndrome [ACS] with significant ≥70% coronary stenosis) at least six months after the event. Acute myocardial infarction will be defined according to the third universal definition of myocardial infarction. Exclusion Criteria: Refused consent Unable to participate or provide written informed consent Short-term survival (<1 year) Acute or decompensated medical conditions Acute neurological or psychiatric diseases Absence of sinus rhythm or frequent ectopic beats History of severe lung, liver, kidney or autoimmune diseases Any contraindication to MRI

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiac X Syndrome (CSX)<br>patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007) | Other: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)<br> <br> Other: Million Clinical Multiaxial Inventory 3 (MCMI-III)<br> <br> Other: State-Trait Anxiety Inventory form Y (STAI-Y)<br> <br> Other: SF-36 Health-Related Quality of Life<br> <br> Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)<br> <br> |
| Other: Takotsubo Cardiomyopathy (TTC)<br>Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008) | Other: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)<br> <br> Other: Million Clinical Multiaxial Inventory 3 (MCMI-III)<br> <br> Other: State-Trait Anxiety Inventory form Y (STAI-Y)<br> <br> Other: SF-36 Health-Related Quality of Life<br> <br> Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)<br> <br> |
| Other: Acute myocardial infarction (AMI)<br>Type 1, 4a, 4b myocardial infarction (ST-segment elevation acute myocardial infarction [STEMI] and Non ST-segment elevation acute myocardial infarction [NSTEMI] acute coronary syndrome [ACS] with significant ≥70% coronary stenosis) at least six months after the event. (Thygesen K, et al. Eur Heart J. 2012) | Other: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)<br> <br> Other: Million Clinical Multiaxial Inventory 3 (MCMI-III)<br> <br> Other: State-Trait Anxiety Inventory form Y (STAI-Y)<br> <br> Other: SF-36 Health-Related Quality of Life<br> <br> Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients |  | Baseline | 
| Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in CSX and TTC AMDP 8 results as compared to AMI patients |  | Baseline | 
| Difference in CSX and TTC MCMI-III results as compared to AMI patients |  | Baseline | 
| Difference in CSX and TTC STAI-Y results as compared to AMI patients |  | Baseline | 
| Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients |  | Baseline |