Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X:
NCT ID: NCT02759341
Last Updated: 2017-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-02-29
2017-11-30
Brief Summary
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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
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Cardiac X Syndrome (CSX)
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
Manual for the Assessment and Documentation of Psychopathology (AMDP 8)
Million Clinical Multiaxial Inventory 3 (MCMI-III)
State-Trait Anxiety Inventory form Y (STAI-Y)
SF-36 Health-Related Quality of Life
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)
Manual for the Assessment and Documentation of Psychopathology (AMDP 8)
Million Clinical Multiaxial Inventory 3 (MCMI-III)
State-Trait Anxiety Inventory form Y (STAI-Y)
SF-36 Health-Related Quality of Life
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)
Manual for the Assessment and Documentation of Psychopathology (AMDP 8)
Million Clinical Multiaxial Inventory 3 (MCMI-III)
State-Trait Anxiety Inventory form Y (STAI-Y)
SF-36 Health-Related Quality of Life
Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)
Interventions
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Manual for the Assessment and Documentation of Psychopathology (AMDP 8)
Million Clinical Multiaxial Inventory 3 (MCMI-III)
State-Trait Anxiety Inventory form Y (STAI-Y)
SF-36 Health-Related Quality of Life
Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Swiss Heart Foundation
OTHER
Ospedale San Giovanni Bellinzona
OTHER
Responsible Party
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Mattia Cattaneo
M.D.
Principal Investigators
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Mattia Cattaneo, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Giovanni Bellinzona
Augusto Gallino, MD
Role: STUDY_CHAIR
Ospedale San Giovanni Bellinzona
Locations
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Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona
Bellinzona, Canton Ticino, Switzerland
Countries
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References
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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.
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.
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.
Other Identifiers
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2016-00015
Identifier Type: OTHER
Identifier Source: secondary_id
CE 3015
Identifier Type: -
Identifier Source: org_study_id