Brain fMRT In Takotsubo Cardiomyopathy

NCT02240056 | Completed

• 1 other identifier: TAKINSULA
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Cardiomyopathy

Outcome Measures

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

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

Study Arms (3)

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

Eligibility Criteria

• Age: Up to 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal women with TTC or NSTEMI / STEMI aged below 90 years

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wolfgang Dichtl, MD PhD: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Wolfgang Dichtl, MD PhD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Priv.Doz. DDr.

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

AU (1)