NCT02350010

Brief Summary

There were lack of data and analysis about medical management, etiology, and long-term outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further the investigators will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

January 7, 2015

Last Update Submit

January 26, 2015

Conditions

Intracerebral Hemorrhage

Keywords

EtiologyPrognostic risk factorsIntracerebral Hemorrhagenon-invasive imagingCT angiography

Outcome Measures

Primary Outcomes (1)

  • one-year functional outcome and mortality of Intracerebral hemorrhage.

    Good functional outcome was defined as modified Rankin Scale score (mRS) ≤2.

    one year

Interventions

CT AngiographyDEVICE

CTA Scan with the specified sequences below: 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Coronal and sagittal multiplanar reconstructed images with 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing. 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s.

Eligibility Criteria

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

Patients admitted with CT-demonstrated Intracerebral Hemorrhage (ICH) within 72 hours after symptom onset.

You may qualify if:

  • CT demonstrated ICH
  • Age above 18
  • within 72 hours of symptom onset
  • Informed consent from patient or proxy

You may not qualify if:

  • allergy to contrast medium incompletion of a standard CT protocol including noncontrast CT (NCCT) and CTA Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Neurosurgical Institute

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (7)

  • Hemphill JC 3rd, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001 Apr;32(4):891-7. doi: 10.1161/01.str.32.4.891.

    PMID: 11283388BACKGROUND

  • Hemphill JC 3rd, Farrant M, Neill TA Jr. Prospective validation of the ICH Score for 12-month functional outcome. Neurology. 2009 Oct 6;73(14):1088-94. doi: 10.1212/WNL.0b013e3181b8b332. Epub 2009 Sep 2.

    PMID: 19726752BACKGROUND

  • Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.

    PMID: 19233729BACKGROUND

  • van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.

    PMID: 20056489BACKGROUND

  • Zhang LF, Yang J, Hong Z, Yuan GG, Zhou BF, Zhao LC, Huang YN, Chen J, Wu YF; Collaborative Group of China Multicenter Study of Cardiovascular Epidemiology. Proportion of different subtypes of stroke in China. Stroke. 2003 Sep;34(9):2091-6. doi: 10.1161/01.STR.0000087149.42294.8C. Epub 2003 Aug 7.

    PMID: 12907817BACKGROUND

  • Jiang B, Wang WZ, Chen H, Hong Z, Yang QD, Wu SP, Du XL, Bao QJ. Incidence and trends of stroke and its subtypes in China: results from three large cities. Stroke. 2006 Jan;37(1):63-8. doi: 10.1161/01.STR.0000194955.34820.78. Epub 2005 Nov 23.

    PMID: 16306469BACKGROUND

  • Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.

    PMID: 20651276BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Computed Tomography Angiography

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Wen-Zhi Wang, professor

    Beijing Neurosurgical Institute

    STUDY CHAIR

Central Study Contacts

Wen-Zhi Wang, professor

CONTACT

0086-010-65112838qgnfbwwz@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations

CN(1)