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Takotsubo CardiomyopathyNCT02659878

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

An observational study of Takotsubo Cardiomyopathy and Subarachnoid Hemorrhage, run by University of Debrecen at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bleeding, intraventricular and/ or intracerebral hemorrhage.
Type of treatment
Surgery or procedure
How many people
137 participants
Where
1 siteHungary
Study dates
Feb 2015to 31 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Hungary1 site
  • UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

About this study

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

Pupose:

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

Read more

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.

Read the detailed description

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 prophylaxis, painkillers
  • Fluid therapy: ensuring normovolaemia

Data to be recorded during hospital stay:

  • Localization of the bleeding (is there an aneurysm present, if yes what is its location, size)
  • Is ventricular drain necessary?
  • Treatment methods of the aneurysm:Endovascular, aneurysm clipping
  • Time passed between bleeding and treatment (in hours)

The following investigations are repeated daily:

  • 12-lead ECG
  • Myocardial necrotic enzymes (checked daily over 1 week even if no ECG abnormalities are present) : cardiac troponin I (cTnI), creatine kinase (CK), CK-MB, Brain natriuretic peptide (BNP), N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
  • In case of ECG abnormalities echocardiography should take place on the same day (with video recording)
  • If there are no ECG abnormalities echocardiography should be controlled once within the first week (with video recording)
  • Transcranial Color Doppler (TCCD)
  • Glasgow Coma Scale (GCS)
  • Recording the currently used medicines with accurate doses (with special attention to the positive inotropic agents and drugs with vasoconstrictor properties)
  • In case of mechanical ventilation:Fraction of inspired oxygen (FiO 2), Positive end expiratory pressure (PEEP), Blood gas analysis (PaO 2, PaCO 2), Peak pressure (PPeak)
  • Noting the presence of pulmonary edema (auscultation, blood gas analysis) If Takotsubo cardiomyopathy is diagnosed, the 24-hour urine collection test should be repeated (measure the quantity of collected urine, determine urine metanephrine and normetanephrine levels)

The following diagnostic steps should be repeated after 1 month:

  • Echocardiography
  • 12-lead ECG
  • New York Heart Association scores (NYHA scores)
  • Glasgow outcome scale (GOS) - survival index
  • Bartel Index, Karnofsky score - index of life quality
  • The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels

If echocardiography shows cardiac wall motion abnormality, cardiac examination should be carried out as the following:

  • Cardiac stress test if necessary
  • CT coronary angiogram if necessary
  • Coronary angiography if necessary

The following examinations should be carried out after 6 months:

  • Echocardiography
  • 12-lead ECG
  • New York Heart Association scores (NYHA scores)
  • Glasgow outcome scale (GOS) - survival index
  • Bartel Index
  • The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels

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.

Being tested
bleeding, intraventricular and/ or intracerebral hemorrhage.
Keywords
Takotsubo cardiomyopathy;NT-proBNP;urine metanephrine
Medical subject headings
Takotsubo Cardiomyopathy, Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bleeding, intraventricular and/ or intracerebral hemorrhage.Procedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia

    12-lead ECD

    Measured: Data to be registered within 24 hours after admittance

  2. ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia

    12-lead ECD

    Measured: The following diagnostic steps should be repeated after 1 month

  3. urine metanephrine, normetanephrine levels

    The amount of urine collected in 24 hours and determination of urine metanephrine, normetanephrine levels

    Measured: The amount of urine collected in 24 hours

  4. 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.

    Measured: The following diagnostic steps should be repeated after 1 month

  5. 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)

    Measured: Data to be registered within 24 hours after admittance

  6. 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)

    Measured: The following diagnostic steps should be repeated after 1 month

  7. Ejection fraction%, exact location and degree of cardiac wall motion abnormalities

    Echocardiography documented with video recording

    Measured: Data to be registered within 24 hours after admittance

  8. Ejection fraction%, exact location and degree of cardiac wall motion abnormalities

    Echocardiography documented with video recording

    Measured: The following diagnostic steps should be repeated after 1 month

Secondary outcomes (1)
  1. 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

    Measured: The following examinations should be carried out after 6 months:

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completion30 Jun 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659878
Sponsor's protocol ID
HBR/052/00436-2/2015
Other IDs
DE RKEB/IKEB:4317-2015
Status last verified
Jun 2022
First submitted
11 Jan 2016
Last updated
28 Jun 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21629203
  • 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.

    PubMed 35617162

Questions about this trial

What is this clinical trial studying?

An observational study of Takotsubo Cardiomyopathy and Subarachnoid Hemorrhage, run by University of Debrecen at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ECG abnormalities:Corrected QT Interval (QTc), T wave, ST segment, arrhythmia (time frame: Data to be registered within 24 hours after admittance). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659878, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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