Clinical Trials Directory

Trials / Completed

CompletedNCT04554368

A Novel Score to Predict Risk of Symptomatic Intracerebral Hemorrhage

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

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREintra-arterial contrast enhanced Flat Detector CTAfter 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.

Timeline

Start date
2015-06-01
Primary completion
2019-12-31
Completion
2020-03-30
First posted
2020-09-18
Last updated
2023-11-24

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04554368. Inclusion in this directory is not an endorsement.