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| ID | Type | Description | Link |
|---|---|---|---|
| DE RKEB/IKEB:4317-2015 | Registry Identifier | REGIONAL AND INSTITUTIONAL ETHICS COMMITTEE, CLINICAL CENTER, UNIVERSITY OF DEBRECEN |
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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:
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bleeding, intraventricular and/ or intracerebral hemorrhage. | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia | 12-lead ECD | Data to be registered within 24 hours after admittance |
| ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia | 12-lead ECD | The following diagnostic steps should be repeated after 1 month |
| urine metanephrine, normetanephrine levels | The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels | The amount of urine collected in 24 hours |
| urine metanephrine, normetanephrine levels | 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 following diagnostic steps should be repeated after 1 month |
| 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) | Data to be registered within 24 hours after admittance |
| 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 following diagnostic steps should be repeated after 1 month |
| Ejection fraction%, exact location and degree of cardiac wall motion abnormalities |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association scores (NYHA scores) Glasgow outcome scale (GOS) - survival index Neurological status | Clinical outcome (GOS), quality of life (Bartel Index) and Karnofsky scores | The following examinations should be carried out after 6 months: |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Csilla Molnár, MD,PhD | UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21629203 | Background | Castillo Rivera AM, Ruiz-Bailen M, Rucabado Aguilar L. Takotsubo cardiomyopathy--a clinical review. Med Sci Monit. 2011 Jun;17(6):RA135-47. doi: 10.12659/msm.881800. | |
| 35617162 | Derived | Molnar C, Gal J, Szanto D, Fulop L, Szegedi A, Siro P, Nagy EV, Lengyel S, Kappelmayer J, Fulesdi B. Takotsubo cardiomyopathy in patients suffering from acute non-traumatic subarachnoid hemorrhage-A single center follow-up study. PLoS One. 2022 May 26;17(5):e0268525. doi: 10.1371/journal.pone.0268525. eCollection 2022. |
| Label | URL |
|---|---|
| Takotsubo cardiomyopathy - The current state of knowledge Agata Bielecka-Dabrowa, Dimitri P. Mikhailidis, Simon Hannam, Jacek Rysz, Marta Michalska, Yoshihiro J. Akashi, Maciej Banach | View source |
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| ID | Term |
|---|---|
| D054549 | Takotsubo Cardiomyopathy |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018487 | Ventricular Dysfunction, Left |
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Echocardiography documented with video recording |
| Data to be registered within 24 hours after admittance |
| Ejection fraction%, exact location and degree of cardiac wall motion abnormalities | Echocardiography documented with video recording | The following diagnostic steps should be repeated after 1 month |
| Usefulness of MRI in takotsubo cardiomyopathy: a review of the literature Andres Alejandro Kohan1 | View source |
| D018754 |
| Ventricular Dysfunction |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |