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Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT02659878
Recruitment Status : Unknown
Verified March 2017 by Tamas Vegh, MD, University of Debrecen.
Recruitment status was:  Recruiting
First Posted : January 21, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

Brief Summary:

Pupose:

Takotsubo cardiomyopathy is a rare and not well-known complication of the subarachnoid hemorrhage.

This form of heart failure, called as "broke heart" or "apical ballooning syndrome", was first described by Japanese authors at the beginning of 1990's.

1.5-2.2% of acute coronary syndrome is Takotsubo cardiomyopathy. Its predisposing factors, hypothetical parthenogenesis, diagnostic criteria and therapeutic methods are already known from the literature.

The study intends to include all patients over 18 years of age who were admitted to our clinic within 48 hours after the bleeding regardless of gender, neurological status or age.

Data to be registered within 24 hours after admittance:

Instruments:

  • Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler; systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio, pulsatility index
  • ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia
  • Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion abnormalities) - documented with video recording

Hypothesis:

The risk of Takotsubo cardiomyopathy (TS) is increased if SAH is associated with more severe state, a greater degree of bleeding, intraventricular and/ or intracerebral hemorrhage.

The definitive care of patients is postponed due to the appearance of TS, which could affect the final outcome.


Condition or disease Intervention/treatment
Takotsubo Cardiomyopathy Subarachnoid Hemorrhage Procedure: bleeding, intraventricular and/ or intracerebral hemorrhage.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Incidence, Influencing Factors and Outcome of Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: bleeding, intraventricular and/ or intracerebral hemorrhage.
    Patient's age, sex, comorbidities, medications, the exact time point of bleeding, the circumstances of bleeding neurological and cardiological status are recorded, laboratory tests, Transcranial Color Doppler (TCCD), echocardiography and chest X-ray examinations are carried out within 24 hours after the patient is being admitted to the ICU.


Primary Outcome Measures :
  1. ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia [ Time Frame: Data to be registered within 24 hours after admittance ]
    12-lead ECD

  2. ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia [ Time Frame: The following diagnostic steps should be repeated after 1 month ]
    12-lead ECD

  3. urine metanephrine, normetanephrine levels [ Time Frame: The amount of urine collected in 24 hours ]
    The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels

  4. urine metanephrine, normetanephrine levels [ Time Frame: The following diagnostic steps should be repeated after 1 month ]
    The level of metanephrine and normetanephrine from 24-hour collected urine should be measured again after 1 and 6 months in case of patients where TS was diagnosed.

  5. Enzyme level associated with myocardial tissue necrosis [ Time Frame: Data to be registered within 24 hours after admittance ]
    Cardiac troponin I (cTnI), creatine kinase (CK), CK-MB, Brain natriuretic peptide (BNP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

  6. Enzyme level associated with myocardial tissue necrosis [ Time Frame: The following diagnostic steps should be repeated after 1 month ]
    Cardiac troponin I (cTnI), creatine kinase (CK), CK-MB, Brain natriuretic peptide (BNP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP)

  7. Ejection fraction%, exact location and degree of cardiac wall motion abnormalities [ Time Frame: Data to be registered within 24 hours after admittance ]
    Echocardiography documented with video recording

  8. Ejection fraction%, exact location and degree of cardiac wall motion abnormalities [ Time Frame: The following diagnostic steps should be repeated after 1 month ]
    Echocardiography documented with video recording


Secondary Outcome Measures :
  1. New York Heart Association scores (NYHA scores) Glasgow outcome scale (GOS) - survival index Neurological status [ Time Frame: The following examinations should be carried out after 6 months: ]
    Clinical outcome (GOS), quality of life (Bartel Index) and Karnofsky scores



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study intends to include all patients over 18 years of age who were admitted to our clinic within 48 hours after the bleeding regardless of gender, neurological status or age.
Criteria

Inclusion Criteria:

  • Acute subarachnoid hemorrhage
  • Admittance to the neurosurgery intensive care unit within 48 hours after the bleeding has occurred
  • Over 18 years of age
  • No prior cardiological diseases in medical history

Exclusion Criteria:

  • Known myocardial diseases (previous myocardial infarction)
  • Preexisting heart failure
  • Previously known structural heart disease (severe, clinically significantvalve insufficiency, and / or significant stenosis)
  • Preexisting myocarditis
  • Preexisting phaecromocytoma
  • Preexisting hypertrophic cardiomyopathy (Left ventricle > 15 mm)
  • Preexisting coronary artery stenosis that requires dilation (patients should be excluded if coronary artery stenosis with dilation need is confirmed during the follow-up period)

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): NCT02659878


Contacts
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Contact: Judit Gál, MD +36-52-255-347 anesztezia@hotmail.com
Contact: Erzsébet Igbonu-Nagy +36-20-3991551 nagyboske@yahoo.com

Locations
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Hungary
UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Recruiting
Debrecen, Hajdú-Bihar, Hungary, 4032
Contact: Judit Gál, MD    +36-52-255-347    anesztezia@hotmail.com   
Contact: Csilla Molnár, MD, PhD    +36-30-299-8097    csmolnar@med.unideb.hu   
Sponsors and Collaborators
University of Debrecen
Investigators
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Principal Investigator: Csilla Molnár, MD,PhD UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

Additional Information:
Publications:
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Responsible Party: Tamas Vegh, MD, assistant lecturer anesthesiologist and intensive care specialist, University of Debrecen
ClinicalTrials.gov Identifier: NCT02659878     History of Changes
Other Study ID Numbers: HBR/052/00436-2/2015
DE RKEB/IKEB:4317-2015 ( Registry Identifier: REGIONAL AND INSTITUTIONAL ETHICS COMMITTEE, CLINICAL CENTER, UNIVERSITY OF DEBRECEN )
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Tamas Vegh, MD, University of Debrecen:
Takotsubo cardiomyopathy;NT-proBNP;urine metanephrine
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction