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Clinical Trials/NCT01585311
NCT01585311
Terminated
Not Applicable

Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH)

Columbia University1 site in 1 country1,540 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subarachnoid Hemorrhage (SAH)
Sponsor
Columbia University
Enrollment
1540
Locations
1
Primary Endpoint
modified Rankin Scale (mRS) score
Status
Terminated
Last Updated
6 years ago

Overview

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).

Detailed Description

The design of the current study will be to conduct a retrospective analysis of prolonged heart rate and uncontrolled tachycardia using patients enrolled in the investigators prospective observational cohort study since the electronic medical record systems have been implemented. The investigators know that there have been periods when these electronic systems have failed, resulting in lost data. The investigators anticipate retrospective collection of hourly heart rate for approximately 400 SAH patients that will have ICU data and 3 month modified Rankin documented in our Subarachnoid Hemorrhage Outcomes Project (SHOP) database. The investigators will determine what percent of them have prolonged elevated heart rate and tachycardia. Prolonged heart rate and uncontrolled tachycardia has been defined as a heart rate greater than 95 for greater than 12 hours in one 24 hour period of their ICU stay. The investigators will conduct a ROC curve analysis to determine the appropriate heart rate and duration thresholds that are most predictive of poor prognosis after SAH. Patients be will stratified based on several criteria including admission coma score, early (SAH day 0 to 3) or late (SAH day \>=4) ICU admission, presence of intraventricular hemorrhage on admission CT, history of beta-blocker usage, age, and gender.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
August 2015
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

modified Rankin Scale (mRS) score

Time Frame: Three months

Secondary Outcomes

  • Prevalence of Major Adverse Cardiovascular Events (MACE)(3 months)

Study Sites (1)

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