A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04554368

Collaborator

The First Affiliated Hospital of Zhengzhou University (Other)

300

Enrollment

Location

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study sought to develop and validate a new risk stratification score (Henan predicting the risk of intracerebral hemorrhage score, Henan-PRIHS) based on intra-arterial contrast enhanced Flat Detector CT (IA-CEFDCT) to predict symptomatic intra-cerebral hemorrhage (sICH) after stroke thrombectomy.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage Thrombectomy Stroke	Procedure: intra-arterial contrast enhanced Flat Detector CT

Detailed Description

The Henan-PRIHS was developed from 95 patients who underwent IA-CEFDCT and MT for acute anterior stroke. Patients were classified as having one of three grades according to the presence of contrast filling within the occluded vascular territory. Grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively. The Youden index was used to determine the optimum no contrast filling area cutoff for defining grade 1 and 2. The score was subsequently validated in a different population of 208 patients and compared with three established scores.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

300 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage After Stroke Thrombectomy: Derivation, Validation and Comparison With Other Scores

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
IA-CEFDCT group 95 patients who underwent IA-CEFDCT and MT for acute anterior stroke.	Procedure: intra-arterial contrast enhanced Flat Detector CT After femoral artery puncture, FDCT scan (if necessary) and IA-CEFDCT scan were performed on a single flat-detector angiography system (Allura Xper FD20, Philips Medical systems, Best, the Netherlands), respectively. FDCT was acquired with the following acquisition parameters: 20s rotation, 220° rotation, 617 single frames at a frame rate of 30/s, 48cm detector field of view, 1024 acquisition matrix. Images were reconstructed using a soft-tissue kernel with an isotropic voxel size of 0.9 × 0.9 × 0.9 mm on a dedicated workstation for FPCT data (XperCT Dual 3.2.0). For image analysis, these isotropic FDCT data were viewed in the axial plane with 5 mm slice thickness.

Arm

Intervention/Treatment

IA-CEFDCT group

95 patients who underwent IA-CEFDCT and MT for acute anterior stroke.

Procedure: intra-arterial contrast enhanced Flat Detector CT

After femoral artery puncture, FDCT scan (if necessary) and IA-CEFDCT scan were performed on a single flat-detector angiography system (Allura Xper FD20, Philips Medical systems, Best, the Netherlands), respectively. FDCT was acquired with the following acquisition parameters: 20s rotation, 220° rotation, 617 single frames at a frame rate of 30/s, 48cm detector field of view, 1024 acquisition matrix. Images were reconstructed using a soft-tissue kernel with an isotropic voxel size of 0.9 × 0.9 × 0.9 mm on a dedicated workstation for FPCT data (XperCT Dual 3.2.0). For image analysis, these isotropic FDCT data were viewed in the axial plane with 5 mm slice thickness.

Outcome Measures

Primary Outcome Measures

Henan predicting the risk of intracerebral hemorrhage score [5 days]
Grade 0 was normal or less contrast filling in affected hemisphere, grade 1 and 2 were small and medium-large area without contrast filling, respectively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age ≥18 years,
occlusion of internal carotid artery and/or middle cerebral artery (MCA) M1 or M2 segments confirmed by CTA or MRA or DSA,
baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points,
MT was performed within 9 hours from stroke onset,
baseline CT scan and IA-CEFDCT scan must be performed; 24 hours post-treatment CT scan was done and when the patient's neurological state had deteriorated.

Exclusion Criteria:

bilateral infarcts,
history of stroke,
post-procedure ICH (including SAH) due to iatrogenic complications,
missing clinical and demographic data,
poor-quality IA-CEFDCT scans (i.e., motion artifact) that limited accurate identification of the region of interest. Bridge treatment (combined intravenous thrombolysis with MT) was not excluded from this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai 6th People's Hospital	Shanghai		China	200023

Sponsors and Collaborators

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
The First Affiliated Hospital of Zhengzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yueqi Zhu, Clinical Professor, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

ClinicalTrials.gov Identifier:

NCT04554368

Other Study ID Numbers:

Henan-PRIH score

First Posted:

Sep 18, 2020

Last Update Posted:

Sep 18, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Sep 18, 2020