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OpenTrials
Completed

NCT Number: NCT02240056

Brain fMRT In Takotsubo Cardiomyopathy

Certain cardiac and neurologic diseases influence each other via a still poorly understood "brain-heart axis". Subarachnoidal bleedings are well known to cause ECG alterations resembling those of myocardial infarction, along with a reduction of systolic myocardial function ("neurogenic stunned myocardium"). Alterations of the right insula region by a stroke or intracranial hemorrhage go along with a sympathetic activation (increased circulating catecholamine levels, tachycardia, arterial hypertension). In contrast, alterations of the left insula region often cause vagal reactions such as bradycardia, arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of heart attacks, often caused by psychological or physical stress (death of a beloved one, divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects postmenopausal women.

Functional MRT enables imaging of activated brain regions, either without ("resting state") or with specific stimuli. The investigators speculate that there is a specific involvement of the insula region during TTC.

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Key information

Age range

Up to 90 year

Sex eligibility

Female

Study type

Observational

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal females aged below 90 years
  • Informed written consent
  • TTC or NSTEMI / STEMI undergoing coronary angiography within 24 hours of symptom onset

Exclusion criteria

  • Delayed coronary angiography (> 24 hours after symptom onset)
  • Inability to perform rsfMRT within the first 72 hours after coronary angiography
  • Inability to communicate in German language
  • Contraindications for a MRT examination (including pacemaker, implantable cardioverter-defibrillator, mechanical heart valves, claustrophobia, severe adipositas)
  • Drug addiction, under guardianship
  • Inability to stick to the follow up examination

Treatment and study plan

Primary outcomes

  1. Changes in brain functional MRT (resting state, paradigma) in postmenopausal females suffering from TTC as compared to NSTEMI / STEMI postmenopausal female patients

    Time frame: Within the first 72h after diagnosis and after 4-8 weeks

Sponsors and collaborators

Lead sponsor

Wolfgang Dichtl, MD PhD

Other

Registry information

Official study title

Pilot Study: Central Nervous System and Hormonal Changes In Takotsubo Cardiomyopathy

Acronym: TAKINSULA

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Sep 15, 2014
Registry last updated
Mar 7, 2019

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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