Serial Echocardiography After Subarachnoid Hemorrhage (SEAS)

Serial Echocardiography After Subarachnoid Hemorrhage (S.E.A.S.)

There is increasing interest in myocardial abnormalities following central nervous system events, such as subarachnoid hemorrhage (SAH). These cardiac abnormalities include ECG changes, decreased cardiac output, decreased blood pressure, specific cardiac enzyme elevations, and segmental wall motion abnormalities (SWMA). Interestingly, wall motion abnormalities and ECG changes have shown to be reversible, and therefore the dysfunction has been described as neurogenic myocardial stunning.

The pathophysiology of cardiac dysfunction following SAH has not yet been fully elucidated. Many reports (mainly case reports) have been published, but so far no study has investigated the frequency of these abnormalities in a prospective manner, have correlated the occurrence of the different cardiac abnormalities, and have assessed which clinical variables can predict cardiac dysfunction. And only a limited number of studies have related neurological outcome with cardiac dysfunction.

Study Overview

• Status: Unknown
• Conditions: Subarachnoid Hemorrhage; Myocardial Stunning; Takotsubo Cardiomyopathy

Detailed Description

Objectives: Therefore, our study objectives are: 1) Assessment of the frequency of myocardial dysfunction (segmental wall motion abnormalities, cardiac-specific enzyme elevations, and ECG changes) in patients with SAH. 2) Determination of predictive clinical variables for the occurrence of myocardial dysfunction following SAH. 3) Impact of myocardial dysfunction on neurological prognosis: death, secondary cerebral ischemia, hydrocephalus and rebleeding.

Methods: For this purpose serial echocardiograms and ECGs will be obtained and cardiac enzymes will be measured in 200-400 patients admitted to hospital with SAH in the four participating centers. The clinical variables that will be studied to predict cardiac dysfunction are: medical history, the CT-scan score, circulatory parameters, blood samples, medication, surgical intervention (coiling or clipping), and the neurological condition (Glasgow Coma Scale). The echocardiograms, ECGs and cardiac enzymes will be studied to determine if they have independent prognostic value for the outcome in SAH patients.

Expected Results: As ECG changes and drops in blood pressure are known to occur frequently, the researchers expect to find that cardiac contractile dysfunction in patients with SAH occurs more frequently than is assumed now. Moreover, if cardiac abnormalities have neurological prognostic significance further studies are needed for early recognition and treatment of the cardiac abnormalities in SAH, a condition with a very poor prognosis.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen
  • Rotterdam, Netherlands
    • Erasmus Medical Center Rotterdam
  • Tilburg, Netherlands, 5022 GC
    • Saint Elisabeth Hospital
  • Utrecht, Netherlands
    • University Medical Center Utrecht
  • NH
    • Amsterdam, NH, Netherlands, 1105AZ
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with aneurysmal subarachnoid hemorrhage
• Admitted within 72 hours of the bleed

Exclusion Criteria:

• No informed consent
• Patients or patients' family unwillingness to participate

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: University Medical Center Groningen; UMC Utrecht; Erasmus Medical Center; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Frans C Visser, MD PhD, Amsterdam UMC, location VUmc; Study Director: Ivo A van der Bilt, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Principal Investigator: Gabriel J Rinkel, MD PhD, UMC Utrecht; Principal Investigator: Arthur A Wilde, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• van der Bilt IA, Hasan D, van den Brink RB, Cramer MJ, van der Jagt M, van Kooten F, Regtien JG, van den Berg MP, Groen RJ, Cate FJ, Kamp O, Gotte MJ, Horn J, Girbes AR, Vandertop WP, Algra A, Rinkel GJ, Wilde AA; SEASAH (Serial Echocardiography After Subarachnoid Hemorrhage) Investigators. Time course and risk factors for myocardial dysfunction after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2015 Jun;76(6):700-5; discussion 705-6. doi: 10.1227/NEU.0000000000000699.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Anticipated): June 1, 2008
• Study Completion (Anticipated): June 1, 2008

Study Registration Dates

• First Submitted: July 21, 2005
• First Submitted That Met QC Criteria: July 21, 2005
• First Posted (Estimate): July 25, 2005

Study Record Updates

• Last Update Posted (Estimate): March 27, 2008
• Last Update Submitted That Met QC Criteria: March 26, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: outcome; Subarachnoid hemorrhage; Takotsubo cardiomyopathy; Cardiac abnormalities
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Ventricular Dysfunction, Left; Ventricular Dysfunction; Hemorrhage; Cardiomyopathies; Subarachnoid Hemorrhage; Myocardial Stunning; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 04-193