NCT01585311

Brief Summary

The purpose of this retrospective study is to test the hypothesis that uncontrolled tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after Subarachnoid Hemorrhage (SAH).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

7.4 years

First QC Date

April 24, 2012

Last Update Submit

September 6, 2019

Conditions

Subarachnoid Hemorrhage (SAH)Tachycardia

Keywords

Subarachnoid Hemorrhage (SAH)tachycardiaOutcome

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale (mRS) score

    Three months

Secondary Outcomes (1)

  • Prevalence of Major Adverse Cardiovascular Events (MACE)

    3 months

Study Arms (1)

Subarachnoid Hemorrhage patients

SAH patients with hourly eMR values of Heart Rate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the Columbia Neurocritical Care Unit with a diagnosis of subarachnoid hemorrhage established by computed tomography (CT scan) or xanthochromia of the cerebrospinal fluid if the CT is negative.

You may qualify if:

  • Age \>=18 years
  • Diagnosis of subarachnoid hemorrhage established by computed tomography (CT scan) or xanthochromia of the cerebrospinal fluid if the CT is negative
  • Written informed consent from either the patient or a family member
  • Admitted to the NICU for at least 12 hours

You may not qualify if:

  • Age \< 18yrs
  • traumatic SAH
  • SAH due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Subarachnoid HemorrhageTachycardia

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiac Conduction System Disease

Study Officials

  • Jan Claassen, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • J. Michael Schmidt, PhD

    Columbia University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 25, 2012

Study Start

March 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations

US(1)