Brain fMRT In Takotsubo Cardiomyopathy

Takotsubo Cardiomyopathy Clinical Trial

— TAKINSULA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240056
• Other study ID #: TAKINSULA
• Status: Completed
• Start date: October 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Wolfgang Dichtl, MD PhD

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in brain functional MRT (resting state, paradigma) in postmenopausal females suffering from TTC as compared to NSTEMI / STEMI postmenopausal female patients		Within the first 72h after diagnosis and after 4-8 weeks