Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X:
Not Applicable
Completed
- Conditions
- Takotsubo CardiomyopathyCardiac X SyndromeAcute 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 LifeOther: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)
- Registration Number
- NCT02759341
- Lead Sponsor
- Ospedale San Giovanni Bellinzona
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cardiac X Syndrome (CSX) Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI) patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007) Cardiac X Syndrome (CSX) State-Trait Anxiety Inventory form Y (STAI-Y) patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007) Cardiac X Syndrome (CSX) SF-36 Health-Related Quality of Life patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007) Cardiac X Syndrome (CSX) Manual for the Assessment and Documentation of Psychopathology (AMDP 8) patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007) Takotsubo Cardiomyopathy (TTC) Million Clinical Multiaxial Inventory 3 (MCMI-III) Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008) Acute myocardial infarction (AMI) Manual for the Assessment and Documentation of Psychopathology (AMDP 8) 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) Acute myocardial infarction (AMI) Million Clinical Multiaxial Inventory 3 (MCMI-III) 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) Acute myocardial infarction (AMI) SF-36 Health-Related Quality of Life 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) Cardiac X Syndrome (CSX) Million Clinical Multiaxial Inventory 3 (MCMI-III) patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007) Takotsubo Cardiomyopathy (TTC) Manual for the Assessment and Documentation of Psychopathology (AMDP 8) Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008) Takotsubo Cardiomyopathy (TTC) State-Trait Anxiety Inventory form Y (STAI-Y) Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008) Takotsubo Cardiomyopathy (TTC) Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI) Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008) Acute myocardial infarction (AMI) State-Trait Anxiety Inventory form Y (STAI-Y) 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) Acute myocardial infarction (AMI) Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI) 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) Takotsubo Cardiomyopathy (TTC) SF-36 Health-Related Quality of Life Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
- Primary Outcome Measures
Name Time Method Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients Baseline Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients Baseline
- Secondary Outcome Measures
Name Time Method Difference in CSX and TTC AMDP 8 results as compared to AMI patients Baseline Difference in CSX and TTC MCMI-III results as compared to AMI patients Baseline Difference in CSX and TTC STAI-Y results as compared to AMI patients Baseline Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients Baseline
Trial Locations
- Locations (1)
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona
🇨🇭Bellinzona, Canton Ticino, Switzerland