NCT02225730

Brief Summary

Stroke is caused by a sudden blockage of a blood vessel that delivers blood to the brain. Unblocking the blood vessel with a blood clot removal device restores blood flow and if done quickly may prevent the disability that can be caused by a stroke. However, not all stroke patients benefit from having their blood vessel unblocked. The aim of this study is to determine if special brain imaging, called MRI, can be used to identify which stroke patients are most likely to benefit from attempts to unblock their blood vessel with a special blood clot removal device. In particular, we will assess in this trial whether a noncontrast MR imaging sequence, arterial spin labeling (ASL), can demonstrate the presence of collateral blood flow (compared with a gold standard of the angiogram) and whether it is useful to predict who will benefit from treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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 Start

First participant enrolled

September 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

6.2 years

First QC Date

August 22, 2014

Last Update Submit

March 17, 2020

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

  • favorable clinical response

    A "favorable clinical response", defined as an 8-point or more improvement on the NIH score when comparing the baseline score to the 30-day score or NIH score of 0 or a 30-day NIH score of 0-1

    day 30

Secondary Outcomes (1)

  • modified Rankin Score

    day 90

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to the hospital with diagnosis of acute ischemic stroke who are scheduled to undergo (or have undergone) acute IA stroke therapy will be screened for study enrollment.

You may qualify if:

  • Age 18 and older
  • Clinical diagnosis of ischemic stroke and an associated score on the NIHSS of 5 or more points
  • Planned to undergo (or has undergone) intra-arterial (IA) thrombectomy and/or thrombolysis for acute hemispheric stroke. (Either as primary therapy or as adjuvant therapy following intravenous tPA treatment)
  • Planned to undergo or has undergone an MR brain scan including MR perfusion imaging (ASL \& bolus PWI) and MR angiography of the circle of Willis prior to IA therapy
  • Intra-arterial thrombectomy can be started within 90 minutes of completion of the MR perfusion scan and within 24 hours of symptom onset (Start of IA therapy is defined as the time of insertion of the femoral artery sheath; Time of brain scan is defined as the time that the scan is completed)
  • Able to obtain informed consent

You may not qualify if:

  • Any pre-existing illness resulting in a modified Rankin Scale Score of 2 or higher prior to the qualifying stroke
  • Creatinine clearance \< 40 ml/min based on the NIDDK four-variable MDRD method (non-weight based)
  • Documented allergy to MR contrast agent
  • MRI contraindications (pacemaker, etc.)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Stanford University Medical Center

Stanford, California, 94035, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Swedish Hospital

Seattle, Washington, 98122, United States

Location

Related Publications (2)

  • Yu Y, Christensen S, Ouyang J, Scalzo F, Liebeskind DS, Lansberg MG, Albers GW, Zaharchuk G. Predicting Hypoperfusion Lesion and Target Mismatch in Stroke from Diffusion-weighted MRI Using Deep Learning. Radiology. 2023 Apr;307(1):e220882. doi: 10.1148/radiol.220882. Epub 2022 Dec 6.

    PMID: 36472536DERIVED

  • Thamm T, Guo J, Rosenberg J, Liang T, Marks MP, Christensen S, Do HM, Kemp SM, Adair E, Eyngorn I, Mlynash M, Jovin TG, Keogh BP, Chen HJ, Lansberg MG, Albers GW, Zaharchuk G. Contralateral Hemispheric Cerebral Blood Flow Measured With Arterial Spin Labeling Can Predict Outcome in Acute Stroke. Stroke. 2019 Dec;50(12):3408-3415. doi: 10.1161/STROKEAHA.119.026499. Epub 2019 Oct 17.

    PMID: 31619150DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gregory Zaharchuk, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiology

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 26, 2014

Study Start

September 1, 2013

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

US(4)