search
Back to results

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

Primary Purpose

Takotsubo Cardiomyopathy, Cardiac X Syndrome, Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
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)
Sponsored by
Ospedale San Giovanni Bellinzona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Takotsubo Cardiomyopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Cardiac X Syndrome (CSX)

Takotsubo Cardiomyopathy (TTC)

Acute myocardial infarction (AMI)

Arm Description

patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)

Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)

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)

Outcomes

Primary Outcome Measures

Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients
Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients

Secondary Outcome Measures

Difference in CSX and TTC AMDP 8 results as compared to AMI patients
Difference in CSX and TTC MCMI-III results as compared to AMI patients
Difference in CSX and TTC STAI-Y results as compared to AMI patients
Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients

Full Information

First Posted
April 25, 2016
Last Updated
November 20, 2017
Sponsor
Ospedale San Giovanni Bellinzona
Collaborators
Swiss Heart Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT02759341
Brief Title
Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X:
Acronym
BRAINHEART
Official Title
Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: a Study on the Brain-heart Interactions in Two Orphan Cardiac Diseases.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Giovanni Bellinzona
Collaborators
Swiss Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Cardiomyopathy, Cardiac X Syndrome, Acute Myocardial Infarction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac X Syndrome (CSX)
Arm Type
Other
Arm Description
patients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
Arm Title
Takotsubo Cardiomyopathy (TTC)
Arm Type
Other
Arm Description
Tako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
Arm Title
Acute myocardial infarction (AMI)
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Manual for the Assessment and Documentation of Psychopathology (AMDP 8)
Intervention Type
Other
Intervention Name(s)
Million Clinical Multiaxial Inventory 3 (MCMI-III)
Intervention Type
Other
Intervention Name(s)
State-Trait Anxiety Inventory form Y (STAI-Y)
Intervention Type
Other
Intervention Name(s)
SF-36 Health-Related Quality of Life
Intervention Type
Other
Intervention Name(s)
Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)
Primary Outcome Measure Information:
Title
Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients
Time Frame
Baseline
Title
Difference in BOLD-fMRI distribution signal in CSX and TTC as compared to AMI patients
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Difference in CSX and TTC AMDP 8 results as compared to AMI patients
Time Frame
Baseline
Title
Difference in CSX and TTC MCMI-III results as compared to AMI patients
Time Frame
Baseline
Title
Difference in CSX and TTC STAI-Y results as compared to AMI patients
Time Frame
Baseline
Title
Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattia Cattaneo, MD
Organizational Affiliation
Ospedale San Giovanni Bellinzona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Augusto Gallino, MD
Organizational Affiliation
Ospedale San Giovanni Bellinzona
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona
City
Bellinzona
State/Province
Canton Ticino
ZIP/Postal Code
6500
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
16399854
Citation
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.
Results Reference
background
PubMed Identifier
18294473
Citation
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.
Results Reference
background
PubMed Identifier
22922414
Citation
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.
Results Reference
background
PubMed Identifier
32727853
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs