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CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage (CT-PIPS)

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ClinicalTrials.gov Identifier: NCT02056769
Recruitment Status : Unknown
Verified February 2019 by Gwynedd Pickett, Nova Scotia Health Authority.
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Gwynedd Pickett, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE February 3, 2014
First Posted Date  ICMJE February 6, 2014
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE April 2014
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • CBF Admit [ Time Frame: Baseline ]
    Cerebral blood flow as measured on CT perfusion study on admission
  • CBV Admit [ Time Frame: Baseline ]
    Cerebral blood volume as measured on CT perfusion study on admission
  • MTT Admit [ Time Frame: Baseline ]
    Mean transit time as measured on CT perfusion study on admission
  • TTP Admit [ Time Frame: Baseline ]
    Time to peak as measured on CT perfusion study on admission
  • CBF day 6 [ Time Frame: Day 6 post-SAH ]
    Cerebral blood flow as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
  • CBV day 6 [ Time Frame: Day 6 post-SAH ]
    Cerebral blood volume as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
  • MTT day 6 [ Time Frame: Day 6 post-SAH ]
    Mean transit time as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
  • TTP day 6 [ Time Frame: Day 6 post-SAH ]
    Time to peak as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Radiation Dose [ Time Frame: 30 days post-SAH ]
Total cumulative radiation dose from cranial imaging (CT Head, CT angiogram, CT perfusion, catheter angiography, endovascular coiling) during the initial hospital admission for SAH, up to 30 days post-SAH.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2014)
Delayed Cerebral Ischemia [ Time Frame: 30 days post-SAH ]
Delayed cerebral ischemia is defined using a consensus recently agreed upon by an international panel of experts: namely, 1) stroke seen on CT or MRI scan, or proven at autopsy (not including stroke related to the aneurysm treatment), or 2) clinical deterioration presumed to be caused by DCI after other causes are excluded.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage
Official Title  ICMJE CT Perfusion Imaging to Predict Vasospasm in Subarachnoid Hemorrhage
Brief Summary Patients with brain hemorrhage resulting from a ruptured aneurysm (SAH) are at risk of developing a condition called vasospasm, one or two weeks after their hemorrhage. This is a major cause of stroke and death following SAH. A special type of CT scan, called CT perfusion, analyzes regional blood flow in the brain. We hypothesize that CT perfusion scans performed on admission and day 6 post-hemorrhage will enable us to predict which patients will go on to develop vasospasm.
Detailed Description

Rupture of a brain aneurysm results in a type of bleeding into the brain called subarachnoid hemorrhage (SAH). This is a substantial cause of morbidity and mortality world-wide: even with the best possible care, up to half of patients die and many are left disabled. Sometimes this is because the immediate brain damage from the bleed is very severe. However, many patients who seem to be doing well at first go on to develop something called "vasospasm": narrowing of large arteries in the brain. This results in the brain not getting enough blood, and the patient can suffer a stroke as a result. The lack of blood to the brain is called delayed cerebral ischemia (DCI), and is the major secondary cause of stroke and death in patients who survived the initial aneurysm rupture.

Vasospasm can be seen on angiograms (blood vessel imaging) in about two-thirds of SAH patients, and causes neurological symptoms of DCI in half of those patients. It usually develops about a week or so after SAH. Early diagnosis and treatment of cerebral vasospasm and delayed cerebral ischemia (DCI) reduces morbidity and mortality in SAH patients.

CT perfusion imaging is able to identify areas of reduced cerebral blood flow that are at risk of DCI and stroke. This technique is able to measure cerebral blood flow and blood volume (CBF, CBV), and calculates two other measures of cerebral perfusion: time to peak intensity (TTP) and mean transit time (MTT). Taken together, these provide information about the amount of blood the brain is receiving and whether the brain is compensating for any reduction in flow. This is helpful because seeing vasospasm on imaging is not enough to predict brain ischemia and stroke; the additional physiological information provided by the perfusion assessment strengthens the diagnosis of DCI. Early evidence suggests that CT perfusion is a fast, accurate, inexpensive and non-invasive method of brain imaging to identify patients with DCI after SAH, and guide appropriate therapy.

If we were able to successfully predict which patients are at high risk of DCI and/or stroke, we could intervene early. This could improve patient outcomes, while potentially allowing better use of limited intensive care and nursing resources. Other studies have shown that patients with DCI had altered perfusion prior to developing clinical symptoms, but we do not know whether we can use CT perfusion to predict patients at risk, or which CT perfusion measurements (e.g., CBF or TTP) are most useful.

The radiation risk associated with CT perfusion imaging is negligible, due to advances in CT technology which allow for routine simultaneous CT perfusion and CT angiogram (CTA) without a significant increase in radiation dose over conventional head CT-CTA alone. Judicious use of CT perfusion, through a structured algorithm that includes routine perfusion scans at admission and during the peak risk period for vasospasm, may actually decrease cumulative radiation dose for patients with SAH, by ruling out perfusion deficit and brain ischemia as a cause of decreased neurological function and limiting repeated angiograms.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Subarachnoid Hemorrhage
  • Delayed Cerebral Ischemia
  • Cerebral Vasospasm
  • CT Perfusion
Intervention  ICMJE Radiation: CT Perfusion
Quantitative CT Perfusion imaging
Study Arms  ICMJE Experimental: CT Perfusion
All patients enrolled in the study
Intervention: Radiation: CT Perfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
41
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2014)
40
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is between 18 and 75 years of age (inclusive).
  • Patient has a documented aneurysmal SAH.
  • Patient or next of kin or person with appropriate power of attorney has provided written informed consent.
  • Patient is willing and available for study follow-up visits.
  • Patient has not been previously entered into this study.

Exclusion Criteria:

  • Inability to obtain informed written consent.
  • Patient is < 18 or > 75 years old.
  • Patient is not expected to survive >24 hours (e.g. those presenting with loss of brain stem reflexes, or patients transferred to the Halifax Infirmary ICU for consideration of organ donation rather than active treatment)
  • Patient history indicates high risk of non-compliance (e.g., substance abuse, psychosocial issues, etc.)
  • Patient is currently breast feeding, or pregnant
  • Patient is currently enrolled in another clinical study (device or drug).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056769
Other Study ID Numbers  ICMJE CT-PIPS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gwynedd Pickett, Nova Scotia Health Authority
Study Sponsor  ICMJE Gwynedd Pickett
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gwynedd E Pickett, MD Capital District Health Authority, Halifax, Canada
PRS Account Nova Scotia Health Authority
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP