Subarachnoid Hemorrhage (SAH)NCT01585311
Impact of Tachycardia on Outcome After Subarachnoid Hemorrhage (SAH)
An observational study of Subarachnoid Hemorrhage (SAH) and Tachycardia, run by Columbia University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage (SAH), Tachycardia
- How many people
- 1,540 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18yrs
- traumatic SAH
- SAH due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH)
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).
Read the 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.
- Conditions
- Subarachnoid Hemorrhage (SAH), Tachycardia
- Keywords
- Subarachnoid Hemorrhage (SAH), tachycardia, Outcome
- Medical subject headings
- Subarachnoid Hemorrhage, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid Hemorrhage patients | SAH patients with hourly eMR values of Heart Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS) score
Measured: Three months
Secondary outcomes (1)
Prevalence of Major Adverse Cardiovascular Events (MACE)
- pulmonary edema,
- severe hypertension or
- hypotension requiring IV infusion therapy,
- myocardial infarction, and
- serious cardiac arrhythmias including sudden cardiac arrest.
- length of ICU and hospital stay for patients with and without uncontrolled tachycardia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startMar 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage (SAH)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Jan Claassen, MD, Principal investigator, Columbia UniversityJ. Michael Schmidt, PhD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585311
- Sponsor's protocol ID
- AAAA5384
- Status last verified
- Sep 2019
- First submitted
- 24 Apr 2012
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prolonged Tachycardia on Cardiovascular Morbidity and Outcome After Subarachnoid Hemorrhage (SAH)
- ClinicalTrials.gov ID
- NCT01585311
- Acronym / sponsor ID
- AAAA5384
- Conditions
- Subarachnoid Hemorrhage (SAH), Tachycardia
- Keywords
- Subarachnoid Hemorrhage (SAH), tachycardia, Outcome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,540 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Mar 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid Hemorrhage patients | – | –SAH patients with hourly eMR values of Heart Rate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18yrs
- traumatic SAH
- SAH due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified Rankin Scale (mRS) score
Time frame: Three months
1 secondary outcome
Prevalence of Major Adverse Cardiovascular Events (MACE)
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Claassen, MD principal investigator
Columbia University
J. Michael Schmidt, PhD study director
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage (SAH) and Tachycardia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.