Ischemic StrokeNCT02056821
Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke
An observational study of Ischemic Stroke, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute (< 12 hours) ischemic stroke patients presenting to the Emergency Department
Who may be able to join
- Suspected ischemic stroke within 12 hours of symptom onset
- NIHSS ≥ 4
- Age 18 to 90 years
Who cannot join
- Baseline modified Rankin Scale > 3
- Pregnancy
- Intracranial hemorrhage on head CT
- Mechanical ventilation prior to enrollment
- Inadequate temporal windows for TCD analysis
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.
- Conditions
- Ischemic Stroke
- Keywords
- stroke, transcranial doppler, cerebral blood flow, cardiac output, non-invasive hemodynamic monitoring
- Medical subject headings
- Ischemic Stroke, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow velocities
Cerebral flow velocities determined by bilateral MCA measurements by TCD
Measured: initial 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Principal investigator, Joseph Miller, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056821
- Sponsor's protocol ID
- A20030
- Status last verified
- Jan 2017
- First submitted
- 4 Feb 2014
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller J, Moloney JA, Elagamy N, Tuttle J, Tirgari S, Calo S, Thompson R, Nahab B, Lewandowski C, Levy P. Cerebral blood flow change with fluid resuscitation in acute ischemic stroke. Brain Circ. 2024 Dec 28;10(4):303-307. doi: 10.4103/bc.bc_30_24. eCollection 2024 Oct-Dec.
PubMed 40012591
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects on Cerebral Autoregulation in Acute Stroke
- ClinicalTrials.gov ID
- NCT02056821
- Acronym / sponsor ID
- A20030
- Conditions
- Ischemic Stroke
- Keywords
- stroke, transcranial doppler, cerebral blood flow, cardiac output, non-invasive hemodynamic monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- Feb 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Feb 2014 (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.
This study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. To test this, we will target recruitment of acute ischemic stroke patients who present to the ED within 12 hours of symptoms onset. Enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute (< 12 hours) ischemic stroke patients presenting to the Emergency Department
Key inclusion criteria (3 listed)
- Suspected ischemic stroke within 12 hours of symptom onset
- NIHSS ≥ 4
- Age 18 to 90 years
Key exclusion criteria (5 listed)
- Baseline modified Rankin Scale > 3
- Pregnancy
- Intracranial hemorrhage on head CT
- Mechanical ventilation prior to enrollment
- Inadequate temporal windows for TCD analysis
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
Change in cerebral blood flow velocities
Time frame: initial 24 hours
Cerebral flow velocities determined by bilateral MCA measurements by TCD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 40012591Miller J, Moloney JA, Elagamy N, Tuttle J, Tirgari S, Calo S, Thompson R, Nahab B, Lewandowski C, Levy P. Cerebral blood flow change with fluid resuscitation in acute ischemic stroke. Brain Circ. 2024 Dec 28;10(4):303-307. doi: 10.4103/bc.bc_30_24. eCollection 2024 Oct-Dec.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemic Stroke, run by Henry Ford Health System 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jan 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cerebral blood flow velocities (time frame: initial 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02056821, which also lists 1 linked publication.
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 4 Jan 2017.