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

NCT02759341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-22

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Swiss Heart Foundation

    collaborator OTHER
  • Ospedale San Giovanni Bellinzona

    lead OTHER

Principal Investigators

  • Mattia Cattaneo, MD · Ospedale San Giovanni Bellinzona

  • Augusto Gallino, MD · Ospedale San Giovanni Bellinzona

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759341 on ClinicalTrials.gov