NCT06033378

Brief Summary

An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Sep 2028

Study Start

First participant enrolled

September 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 13, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

September 4, 2023

Last Update Submit

March 10, 2025

Conditions

Blood PressureSubarachnoid HemorrhageAneurysm Cerebral

Keywords

magnetic resonance imagingnorepinephrineblood flow

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    mL/min as measured by MRI

    1 hour

Study Arms (1)

Cerebral blood flow

EXPERIMENTAL

Change in cerebral blood flow with increased systemic blood pressure

Other: Blood pressure elevation

Interventions

Blood pressure elevationOTHER

Increasing systemic blood pressure for measurement of cerebral blood flow changes

Cerebral blood flow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coiled or clipped aneurysm
  • Suspected or confirmed vasospasm

You may not qualify if:

  • BMI \>30
  • Pregnancy
  • Pacemaker or other MRI contraindications
  • Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia.
  • Severe respiratory failure or FiO2 \>0.6
  • Severe kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University Hospital

Umeå, Sweden

RECRUITING

Related Publications (1)

  • Osterlind J, Birnefeld J, Birnefeld E, Hultin M, Qvarlander S, Wahlin A, Holmlund P, Zarrinkoob L. Study protocol: MRI-based assessment of cerebral blood flow under pharmacologically elevated blood pressure in patients under general anesthesia, and in sedated ICU patients with aneurysmal subarachnoid hemorrhage. PLoS One. 2025 Dec 10;20(12):e0338688. doi: 10.1371/journal.pone.0338688. eCollection 2025.

    PMID: 41370289DERIVED

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial Arterial DiseasesAneurysm

Study Officials

  • Laleh Zarrinkoob

    Region Västerbotten

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laleh Zarrinkoob, MD, PhD

CONTACT

+46707567067laleh.zarrinkoob@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

March 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)