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Completed

NCT Number: NCT02759341

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

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.

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Key information

Conditions

Takotsubo Cardiomyopathy Acute Myocardial Infarction Angina Pectoris Cardiac X Syndrome Cardiomyopathies Cardiovascular Diseases Heart Diseases Microvascular Angina Myocardial Ischemia Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Bellinzona, Canton Ticino, 6500, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ospedale San Giovanni Bellinzona

Other

Collaborators

  • Swiss Heart Foundation

Registry information

Official study title

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

Acronym: BRAINHEART

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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