Computed Tomography Perfusion (CTP) to Predict Response t... | NCT01622517

Studies
Computed Tomography Perfusion (CTP) to Predict Response to Recanalization in Ischemic Stroke Project (CRISP)

NCT01622517

Sponsor

Stanford University

Status

Completed

Last Update Posted

Oct 17, 2016Estimated

Enrollment

201Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Jun 15, 2012

First Submission Date that Met QC Criteria

Jun 15, 2012

First Posted Date

Jun 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maarten Lansberg, Assistant Professor, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Name	Class
Saint Luke's Health System	OTHER
University of Pittsburgh	OTHER
Emory University	OTHER
Chatanooga Center for Neurological Research

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall goal of the CTP to predict Response to recanalization in Ischemic Stroke Project (CRISP) is to develop a practical tool to identify acute stroke patients who are likely to benefit from endovascular therapy.

The project has two main parts. During the first part, the investigators propose to develop a fully automated system (RAPID) for processing of CT Perfusion (CTP) images that will generate brain maps of the ischemic core and penumbra. There will be no patient enrollment in part one of this project.

During the second part, the investigators aim to demonstrate that physicians in the emergency setting, with the aid of a fully automated CTP analysis program (RAPID), can accurately predict response to recanalization in stroke patients undergoing revascularization. To achieve this aim the investigators will conduct a prospective cohort study of 240 consecutive stroke patients who will undergo a CTP scan prior to endovascular therapy. The study will be conducted at four sites (Stanford University, St Luke's Hospital, University of Pittsburgh Medical Center, and Emory University/Grady Hospital). Patients will have an early follow-up MRI scan within 12+/-6 hours to assess reperfusion and a late follow-up MRI scan at day 5 to determine the final infarct.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

201Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NIHSS Score	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 a 30-day NIH score of 0-1, will be the primary endpoint for the study	30 Day

Secondary Outcomes

Measure	Description	Time Frame
modified Rankin Score	90 day modified Rankin Score 0-2, 90 day modified Rankin distribution, and 90 day Rankin Score 0-1	90 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be 18 or older;
have a clinical diagnosis of ischemic stroke and a score of 5 or more points on the NIHSSS;
be scheduled to undergo intraarterial (IA) therapy for acute hemispheric stroke (either as primary therapy or as adjuvant therapy following intravenous tPA treatment);
be scheduled to have a standard CT including perfusion imaging and CT angiography of the circle of Willis (CTA) prior to IA therapy;
begin intra-arterial thrombectomy within 90 minutes of completion of the CT scan and within 18 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); and
have provided informed consent.

Exclusion Criteria:

have any pre-existing illness resulting in a modified Rankin Scale Score of 3 or higher prior to the qualifying stroke;
are pregnant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

acute ischemic stroke patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maarten G Lansberg, MD, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Hospital and Clinics		Stanford	California	94305	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33434110	Derived	Dehkharghani S, Lansberg M, Venkatsubramanian C, Cereda C, Lima F, Coelho H, Rocha F, Qureshi A, Haerian H, Mont'Alverne F, Copeland K, Heit J. High-Performance Automated Anterior Circulation CT Angiographic Clot Detection in Acute Stroke: A Multireader Comparison. Radiology. 2021 Mar;298(3):665-670. doi: 10.1148/radiol.2021202734. Epub 2021 Jan 12.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases