UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, 4032, Hungary
NCT Number: NCT02659878
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.
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Notify Me18 year and older
All sexes
Observational
Debrecen, Hajdú-Bihar, 4032, Hungary
Data to be registered within 24 hours after admittance:
Data to be recorded during hospital stay:
The following investigations are repeated daily:
The following diagnostic steps should be repeated after 1 month:
If echocardiography shows cardiac wall motion abnormality, cardiac examination should be carried out as the following:
The following examinations should be carried out after 6 months:
Comments:
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.
The urine of patients who have no diagnosed TS will be solely collected and serve as a control. Only 15 of these urine samples will be randomly measured to metanephrine / normetanephrine.
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.
The medication to prevent vasospasm (Nimodipine, Simvastatin, sustained physiological Mg level) and ulcers, just like the drugs to relief pain are the same in case of all patients.
The goal of fluid therapy is to maintain normovolaemia. The location of the bleeding is recorded (is there any aneurysm, its size is measured; if ventricular drainage is necessary, the method that used to treat aneurysm: endovascular, clipping; time elapsed between bleeding and therapy) 12-lead ECG, cardiac enzymes, TCCD measurement, neurological state, medications and its doses, blood gas analysis in case of mechanical ventilation and ventilation parameters are carried out and recorded on a daily basis.
Cardiac ultrasound and 12-lead ECG examinations are carried out, NYHA scores, clinical outcome (GOS), quality of life (Bartel Index) and Karnofsky scores are recorded after 1 month.
If echocardiography shows cardiac wall motion abnormality, cardiac examination should be carried out as following: cardiac stress test, coronary CT angiogram and coronary angiography if necessary.
Echocardiography, 12-lead ECG examinations are repeated and NYHA scores, clinical outcome (GOS), quality of life (Bartel Index) and Karnofsky scores are recorded after 6 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Data to be registered within 24 hours after admittance
12-lead ECD
Time frame: The following diagnostic steps should be repeated after 1 month
12-lead ECD
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
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.
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)
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)
Time frame: Data to be registered within 24 hours after admittance
Echocardiography documented with video recording
Time frame: The following diagnostic steps should be repeated after 1 month
Echocardiography documented with video recording
Time frame: The following examinations should be carried out after 6 months:
Clinical outcome (GOS), quality of life (Bartel Index) and Karnofsky scores
University of Debrecen
Other
Incidence, Influencing Factors and Outcome of Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage
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