A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

• ClinicalTrials.gov Identifier: NCT04554368
• Recruitment Status: Completed
• First Posted: September 18, 2020
• Last Update Posted: September 18, 2020
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Collaborator: The First Affiliated Hospital of Zhengzhou University
• Information provided by (Responsible Party): Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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
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
• Target Follow-Up Duration: 5 Days
• 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: June 1, 2015
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: March 30, 2020

Groups and Cohorts

Group/Cohort

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 :

1. Henan predicting the risk of intracerebral hemorrhage score [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients with acute anterior circulation stroke

Criteria

Inclusion Criteria:

1. age ≥18 years,
2. occlusion of internal carotid artery and/or middle cerebral artery (MCA) M1 or M2 segments confirmed by CTA or MRA or DSA,
3. baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 points,
4. MT was performed within 9 hours from stroke onset,
5. 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:

1. bilateral infarcts,
2. history of stroke,
3. post-procedure ICH (including SAH) due to iatrogenic complications,
4. missing clinical and demographic data,
5. 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

China

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

More Information

• 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: September 18, 2020
• Last Update Posted: September 18, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Individual participant data will not be made avaliable

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cerebral Hemorrhage; Hemorrhage; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Hemorrhages