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

Not Applicable

Completed

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

• 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

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Status Verified: 2017-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

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

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