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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02759341
Acronym
BRAINHEART
Enrollment
50
Registered
2016-05-03
Start date
2016-02-29
Completion date
2017-11-30
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Cardiac X Syndrome, Takotsubo Cardiomyopathy

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.

Interventions

OTHERManual for the Assessment and Documentation of Psychopathology (AMDP 8)
OTHERMillion Clinical Multiaxial Inventory 3 (MCMI-III)
OTHERState-Trait Anxiety Inventory form Y (STAI-Y)
OTHERSF-36 Health-Related Quality of Life
OTHERBlood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)

Sponsors

Swiss Heart Foundation
CollaboratorOTHER
Ospedale San Giovanni Bellinzona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patientsBaseline
Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patientsBaseline

Secondary

MeasureTime frame
Difference in CSX and TTC AMDP 8 results as compared to AMI patientsBaseline
Difference in CSX and TTC MCMI-III results as compared to AMI patientsBaseline
Difference in CSX and TTC STAI-Y results as compared to AMI patientsBaseline
Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patientsBaseline

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026