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

Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: a Study on the Brain-heart Interactions in Two Orphan Cardiac Diseases.

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction; Takotsubo Cardiomyopathy; Cardiac X Syndrome
• Intervention / Treatment: 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 Life; Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton Ticino
    • Bellinzona, Canton Ticino, Switzerland, 6500
      • Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cardiac X Syndrome (CSX); patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)	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 Life; Other: 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)	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 Life; Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)
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)	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 Life; Other: Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ospedale San Giovanni Bellinzona
• Collaborators: Swiss Heart Foundation
• Investigators: Principal Investigator: Mattia Cattaneo, MD, Ospedale San Giovanni Bellinzona; Study Chair: Augusto Gallino, MD, Ospedale San Giovanni Bellinzona

Publications and helpful links

General Publications

• Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31.
• Lanza GA. Cardiac syndrome X: a critical overview and future perspectives. Heart. 2007 Feb;93(2):159-66. doi: 10.1136/hrt.2005.067330. Epub 2006 Jan 6.
• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
• Cattaneo MM, Pravata E, Provenzi M, Moccetti M, Kaelin A, Sudano I, Biasucci L, Gallino C, Limoni C, Calanchini C, Gallino A, Crea F, Cattaneo M. Role of the central autonomic nervous system intrinsic functional organisation and psychosocial factors in primary microvascular angina and Takotsubo syndrome. Open Heart. 2020 Jul;7(2):e001315. doi: 10.1136/openhrt-2020-001315.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Angina Pectoris; Ventricular Dysfunction, Left; Ventricular Dysfunction; Myocardial Infarction; Infarction; Syndrome; Cardiomyopathies; Microvascular Angina; Takotsubo Cardiomyopathy
• Other Study ID Numbers: CE 3015; 2016-00015 (Other Identifier: Swissethic)