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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Ospedale San Giovanni Bellinzona

Current Primary Outcome:

  • Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients [ Time Frame: Baseline ]
  • Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients [ Time Frame: Baseline ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Difference in CSX and TTC AMDP 8 results as compared to AMI patients [ Time Frame: Baseline ]
  • Difference in CSX and TTC MCMI-III results as compared to AMI patients [ Time Frame: Baseline ]
  • Difference in CSX and TTC STAI-Y results as compared to AMI patients [ Time Frame: Baseline ]
  • Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients [ Time Frame: Baseline ]


Original Secondary Outcome: Same as current

Information By: Ospedale San Giovanni Bellinzona

Dates:
Date Received: April 25, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: April 4, 2017
Last Verified: April 2017