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

Ospedale San Giovanni Bellinzona

Status: Completed

Conditions: Acute Myocardial Infarction; Cardiac X Syndrome; Takotsubo Cardiomyopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02759341

2016-00015 (Other Identifier)

CE 3015

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Cardiac X Syndrome (CSX)

Other group

Description:

patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)

Treatment:

Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)

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: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)

Takotsubo Cardiomyopathy (TTC)

Other group

Description:

Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)

Treatment:

Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)

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: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)

Acute myocardial infarction (AMI)

Other group

Description:

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)

Treatment:

Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)

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: Manual for the Assessment and Documentation of Psychopathology (AMDP 8)