Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: a Study on the Brain-heart Interactions in Two Orphan Cardiac Diseases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Takotsubo Cardiomyopathy (TTC)
Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
干预措施: State-Trait Anxiety Inventory form Y (STAI-Y) (Other)
Cardiac X Syndrome (CSX)
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
干预措施: Manual for the Assessment and Documentation of Psychopathology (AMDP 8) (Other)
Cardiac X Syndrome (CSX)
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
干预措施: Million Clinical Multiaxial Inventory 3 (MCMI-III) (Other)
Cardiac X Syndrome (CSX)
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
干预措施: State-Trait Anxiety Inventory form Y (STAI-Y) (Other)
Cardiac X Syndrome (CSX)
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
干预措施: SF-36 Health-Related Quality of Life (Other)
Cardiac X Syndrome (CSX)
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
干预措施: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI) (Other)
Takotsubo Cardiomyopathy (TTC)
Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
干预措施: SF-36 Health-Related Quality of Life (Other)
Takotsubo Cardiomyopathy (TTC)
Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
干预措施: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI) (Other)
Takotsubo Cardiomyopathy (TTC)
Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
干预措施: Manual for the Assessment and Documentation of Psychopathology (AMDP 8) (Other)
Takotsubo Cardiomyopathy (TTC)
Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
干预措施: Million Clinical Multiaxial Inventory 3 (MCMI-III) (Other)
Acute myocardial infarction (AMI)
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)
干预措施: Manual for the Assessment and Documentation of Psychopathology (AMDP 8) (Other)
Acute myocardial infarction (AMI)
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)
干预措施: Million Clinical Multiaxial Inventory 3 (MCMI-III) (Other)
Acute myocardial infarction (AMI)
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)
干预措施: State-Trait Anxiety Inventory form Y (STAI-Y) (Other)
Acute myocardial infarction (AMI)
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)
干预措施: SF-36 Health-Related Quality of Life (Other)
Acute myocardial infarction (AMI)
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)
干预措施: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI) (Other)
结局指标
主要结局
Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients
时间窗: Baseline
Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients
时间窗: Baseline
次要结局
- 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)
研究者
Mattia Cattaneo
M.D.
Ospedale San Giovanni Bellinzona