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

NCT02659878 | Completed DMC

• 2 other identifiers: HBR/052/00436-2/2015DE RKEB/IKEB:4317-2015
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Takotsubo Cardiomyopathy; Subarachnoid Hemorrhage

Keywords

Takotsubo cardiomyopathy;NT-proBNP;urine metanephrine

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (1)

• New York Heart Association scores (NYHA scores) Glasgow outcome scale (GOS) - survival index Neurological status

  The following examinations should be carried out after 6 months:

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related Publications (2)

• 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.

  PMID: 21629203 BACKGROUND

• 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.

  PMID: 35617162 DERIVED

Related Links

• Usefulness of MRI in takotsubo cardiomyopathy: a review of the literature Andres Alejandro Kohan1

MeSH Terms

Conditions

Takotsubo Cardiomyopathy; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Csilla Molnár, MD,PhD

  UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer anesthesiologist and intensive care specialist

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 21, 2016
• Study Start: February 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

HU (1)