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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Incidence, Influencing Factors and Outcome of Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage

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 pati

Detailed Summary:

Data to be registered within 24 hours after admittance:

  • Age of the patient
  • Gender
  • Comorbidities
  • Currently taken medications
  • The exact time point of bleeding
  • Additional circumstances of the bleeding
  • Physical stress factors
  • Psychological stress factors
  • Significant blood pressure elevation, and its assumed reason
  • Severity of bleeding:Fisher's Grade; Neurological status; Hunt-Hess scale;GCS (Glasgow Coma Scale)
  • Intracranial blood flow characteristics:TCCD - using Transcranial Color Doppler; systolic, diastolic and mean blood flow velocity, Systolic / Diastolic ratio, pulsatility index
  • Cardiac status:Chest pain, Shortness of breath, Pulmonary edema
  • ECG abnormalities: Corrected QT Interval (QTc), T wave, ST segment, arrhythmia
  • Enzyme level associated with myocardial tissue necrosis: Cardiac troponin I (cTnI), creatine kinase (CK), CK-MB, Brain natriuretic peptide (BNP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
  • The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels
  • Chest X-ray
  • Echocardiography (Ejection fraction%, exact location and degree of cardiac wall motion abnormalities) - documented with video recording
  • Medication: Nimodipine, simvastatin, keeping Mg levels in the normal range, ulcer p
    Sponsor: University of Debrecen

    Current Primary Outcome:

    • 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
    • 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
    • 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
    • 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.
    • 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)
    • 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 p

      Original Primary Outcome: Same as current

      Current Secondary Outcome: 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


      Original Secondary Outcome: Same as current

      Information By: University of Debrecen

      Dates:
      Date Received: January 11, 2016
      Date Started: February 2015
      Date Completion: August 2018
      Last Updated: March 8, 2017
      Last Verified: March 2017