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

6 februari 2023 bijgewerkt door: Nova Scotia Health Authority
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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

41

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Halifax Infirmary, Capital District Health Authority

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (VOLWASSEN, OUDER_ADULT)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: DIAGNOSTIEK
  • Toewijzing: NA
  • Interventioneel model: SINGLE_GROUP
  • Masker: GEEN

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
EXPERIMENTEEL: CT Perfusion
All patients enrolled in the study
Quantitative CT Perfusion imaging

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CBF Admit
Tijdsspanne: Baseline
Cerebral blood flow as measured on CT perfusion study on admission
Baseline
CBV Admit
Tijdsspanne: Baseline
Cerebral blood volume as measured on CT perfusion study on admission
Baseline
MTT Admit
Tijdsspanne: Baseline
Mean transit time as measured on CT perfusion study on admission
Baseline
TTP Admit
Tijdsspanne: Baseline
Time to peak as measured on CT perfusion study on admission
Baseline
CBF day 6
Tijdsspanne: Day 6 post-SAH
Cerebral blood flow as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Day 6 post-SAH
CBV day 6
Tijdsspanne: Day 6 post-SAH
Cerebral blood volume as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Day 6 post-SAH
MTT day 6
Tijdsspanne: Day 6 post-SAH
Mean transit time as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Day 6 post-SAH
TTP day 6
Tijdsspanne: Day 6 post-SAH
Time to peak as measured on CT perfusion study on day 6 following subarachnoid hemorrhage
Day 6 post-SAH

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Radiation Dose
Tijdsspanne: 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.
30 days post-SAH

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Delayed Cerebral Ischemia
Tijdsspanne: 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.
30 days post-SAH

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Gwynedd E Pickett, MD, Capital District Health Authority, Halifax, Canada

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (WERKELIJK)

1 april 2014

Primaire voltooiing (WERKELIJK)

1 juni 2018

Studie voltooiing (VERWACHT)

1 februari 2024

Studieregistratiedata

Eerst ingediend

3 februari 2014

Eerst ingediend dat voldeed aan de QC-criteria

5 februari 2014

Eerst geplaatst (SCHATTING)

6 februari 2014

Updates van studierecords

Laatste update geplaatst (WERKELIJK)

8 februari 2023

Laatste update ingediend die voldeed aan QC-criteria

6 februari 2023

Laatst geverifieerd

1 februari 2023

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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