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Brain fMRT In Takotsubo Cardiomyopathy (TAKINSULA)

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ClinicalTrials.gov Identifier: NCT02240056
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Wolfgang Dichtl, MD PhD, Medical University Innsbruck

Brief Summary:

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.


Condition or disease
Takotsubo Cardiomyopathy

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study: Central Nervous System and Hormonal Changes In Takotsubo Cardiomyopathy
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Group/Cohort
TTC
postmenopausal women with acute Takotsubo cardiomyopathy (TTC), diagnosis by coronary angiography within 24 hours of symptom onset
NSTEMI / STEMI
postmenopausal women with acute ST elevation myocardial infarction (NSTEMI / STEMI), diagnosis by coronary angiography within 24 hours of symptom onset
healthy subjects
healthy postmenopausal women without coronary artery disease



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Postmenopausal women with TTC or NSTEMI / STEMI aged below 90 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240056


Locations
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Austria
Medical University Innsbruck
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Wolfgang Dichtl, MD PhD
Investigators
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Principal Investigator: Wolfgang Dichtl, MD PhD Medical University Innsbruck

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Responsible Party: Wolfgang Dichtl, MD PhD, Priv.Doz. DDr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02240056     History of Changes
Other Study ID Numbers: TAKINSULA
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction