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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02759341
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Swiss Heart Foundation
Information provided by (Responsible Party):
Mattia Cattaneo, Ospedale San Giovanni Bellinzona

Study Description
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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.


Condition or disease Intervention/treatment Phase
Takotsubo Cardiomyopathy Cardiac X Syndrome Acute Myocardial Infarction 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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: a Study on the Brain-heart Interactions in Two Orphan Cardiac Diseases.
Study Start Date : February 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)
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)
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)


Outcome Measures
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Primary Outcome Measures :
  1. Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients [ Time Frame: Baseline ]
  2. Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Difference in CSX and TTC AMDP 8 results as compared to AMI patients [ Time Frame: Baseline ]
  2. Difference in CSX and TTC MCMI-III results as compared to AMI patients [ Time Frame: Baseline ]
  3. Difference in CSX and TTC STAI-Y results as compared to AMI patients [ Time Frame: Baseline ]
  4. Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients [ Time Frame: Baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759341


Locations
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Switzerland
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona
Bellinzona, Canton Ticino, Switzerland, 6500
Sponsors and Collaborators
Ospedale San Giovanni Bellinzona
Swiss Heart Foundation
Investigators
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Principal Investigator: Mattia Cattaneo, MD Ospedale San Giovanni Bellinzona
Study Chair: Augusto Gallino, MD Ospedale San Giovanni Bellinzona
More Information
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Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mattia Cattaneo, M.D., Ospedale San Giovanni Bellinzona
ClinicalTrials.gov Identifier: NCT02759341    
Other Study ID Numbers: CE 3015
2016-00015 ( Other Identifier: Swissethic )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Myocardial Infarction
Cardiomyopathies
Microvascular Angina
Takotsubo Cardiomyopathy
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Ventricular Dysfunction, Left
Ventricular Dysfunction