AzTrials
AzTrials

Takotsubo CardiomyopathyBRAINHEARTNCT02759341

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

A study testing Manual for the Assessment and Documentation of Psychopathology (AMDP 8), Million Clinical Multiaxial Inventory 3 (MCMI-III) and State-Trait Anxiety Inventory form Y (STAI-Y) in people with Takotsubo Cardiomyopathy and Cardiac X Syndrome, run by Ospedale San Giovanni Bellinzona at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Manual for the Assessment and Documentation of Psychopathology (AMDP 8), Million Clinical Multiaxial Inventory 3 (MCMI-III) and State-Trait Anxiety Inventory form Y (STAI-Y)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
Feb 2016to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Bellinzona, Canton Ticino, 6500

Other trials in Switzerland

About this study

Official title: 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.

Being tested
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)
Medical subject headings
Takotsubo Cardiomyopathy, Microvascular Angina

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 LifeOther

  • Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)Other

Study groups in NCT02759341
Study groupRoleWhat they receive
Cardiac X Syndrome (CSX)Otherpatients with Cardiac X Syndrome (CSX), according to the diagnostic criteria previously proposed by Lanza (Lanza, Heart. 2007)
Receives: 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)OtherTako-Tsubo Cardiomyopathy (TTC), according to Mayo diagnostic criteria at least six months after the event. (Prasad A, et al. Am Heart J. 2008)
Receives: 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)OtherType 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)
Receives: 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 being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline

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

    Measured: Baseline

Secondary outcomes (4)

  1. Difference in CSX and TTC AMDP 8 results as compared to AMI patients

    Measured: Baseline

  2. Difference in CSX and TTC MCMI-III results as compared to AMI patients

    Measured: Baseline

  3. Difference in CSX and TTC STAI-Y results as compared to AMI patients

    Measured: Baseline

  4. Difference in CSX and TTC SF-36 HRQOL results as compared to AMI patients

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02759341
Sponsor's protocol ID
CE 3015
Other IDs
2016-00015, 2016
Acronym
BRAINHEART
Status last verified
Nov 2017
First submitted
25 Apr 2016
Last updated
22 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16399854

  • 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.

    PubMed 18294473

  • 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.

    PubMed 22922414

  • 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.

    PubMed 32727853

Questions about this trial

What is this clinical trial studying?

A study testing Manual for the Assessment and Documentation of Psychopathology (AMDP 8), Million Clinical Multiaxial Inventory 3 (MCMI-III) and State-Trait Anxiety Inventory form Y (STAI-Y) in people with Takotsubo Cardiomyopathy and Cardiac X Syndrome, run by Ospedale San Giovanni Bellinzona at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in BOLD-fMRI intensity signal in CSX and TTC as compared to AMI patients (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02759341, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.

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