NCT02759341

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ospedale San Giovanni Bellinzona · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Takotsubo Cardiomyopathy
• Cardiac X Syndrome
• Acute Myocardial Infarction

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-05-03
• Last updated: 2017-11-22

Locations

1 site across 1 country: Switzerland