NCT00123695

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

3.1 years

First QC Date

July 21, 2005

Last Update Submit

March 26, 2008

Conditions

Subarachnoid HemorrhageMyocardial StunningTakotsubo Cardiomyopathy

Keywords

Subarachnoid hemorrhageTakotsubo cardiomyopathyCardiac abnormalitiesoutcome

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Erasmus Medical Center Rotterdam

Rotterdam, Netherlands

Location

Saint Elisabeth Hospital

Tilburg, 5022 GC, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25714519DERIVED

MeSH Terms

Conditions

Subarachnoid HemorrhageMyocardial StunningTakotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesSigns and SymptomsCardiomyopathiesVentricular Dysfunction, LeftVentricular Dysfunction

Study Officials

  • Frans C Visser, MD PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

  • Ivo A van der Bilt, MD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY DIRECTOR

  • Gabriel J Rinkel, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Arthur A Wilde, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2005

First Posted

July 25, 2005

Study Start

May 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

NL(6)