Etiology and Prognostic Risk Factors of Intracerebral Hemorrhage in Beijing

January 26, 2015 updated by: Beijing Neurosurgical Institute

The Research of Etiology and Risk Factors Related to Prognosis of Intracerebral Hemorrhage in Beijing

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intracerebral hemorrhage (ICH) accounts for 10 %-15 % of all strokes and is one of leading causes of stroke related mortality and morbidity worldwide. Despite advances in medical knowledge, treatment for ICH remains strictly supportive. ICH accounted for 26.7～51.5% of stroke in China, the proportion was higher than in Western countries. There were lack of data and analysis about medical management, etiology, and long-term outcome of ICH in Beijing.

In this study we do acute CT angiography (CTA), a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further we will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH. There are some studies of CTA to assess the cause of ICH and functional outcomes, but lack of multi-center, large sample studies to support and validate these findings, particularly fewer application of postcontrast CT. This would allow an early intervention base on different causes and Select treatment decisions according to risk score.

We are planning to:

When patients with ICH arrive in stroke department of the topic cooperation hospitals within 72 hours after symptom onset, they will be subject to CTA with the protocoled sequences.

Standard sequences: Pre- and postcontrast head imaging is acquired from the skull base to vertex with parameters: 120 kVp; 340 mA; 4x5 mm collimation; 1second/rotation; and a table speed of 15 mm/rotation. CTA was performed immediately after initial noncontrast CT(NCCT) performance using a bolus-tracking method by injecting 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s. The protocol for the circle of Willis was 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Postprocessing procedure including multiplanar reconstruction was performed by a CT technologist at the CT operator's discretion for assessment of contrast extravagation and etiologies of ICH such as vascular malformation, and venous sinus thrombosis. Coronal and sagittal multiplanar reconstructed images were created as 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing.

Clinical data of patients with ICH will be collected by 2 neurologists blinded to the radiological data during patients' hospitalization and at the 3-month, 6-month, and 1-year follow-up. The collected demographic and clinical variables included gender, age, body mass index, alcohol and tobacco use, history of hypertension, diabetes, hyperlipidemia, stroke, coronary heart disease, and medications (antihypertensive, antiplatelet, and anticoagulation agents). The systolic and diastolic blood pressure of patients will be recorded. Stroke severity on admission will be evaluated by Glasgow Coma Scale and National Institutes of Health Stroke Scale. Laboratory tests on admission included white blood cell count, hemoglobin, platelet count, serum glucose, serum creatinine, fibrinogen, activated partial thromboplastin time, and prothrombin time as expressed by the international normalized ratio. Length of hospital stay was recorded. The patients' clinical outcome will be assessed by modified Rankin Scale on discharge and 30-day, 3-month, 6-month, and 1-year.

To sum up the purpose of this present study is to explore etiology and prognostic risk factors of ICH by acute CTA and develop and validate a risk score for predicting 1-year functional outcome after ICH.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen-Zhi Wang, professor
  • Phone Number: 0086-010-65112838
  • Email: qgnfbwwz@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing Neurosurgical Institute
        • Contact:
          • Wen-Zhi Wang, professor
          • Phone Number: 0086-010-65112838
          • Email: qgnfbwwz@163.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
one-year functional outcome and mortality of Intracerebral hemorrhage.
Time Frame: one year
Good functional outcome was defined as modified Rankin Scale score (mRS) ≤2.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Collaborators

Beijing Tiantan Hospital
Peking University Third Hospital
Beijing Shijitan Hospital, Capital Medical University
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Fu Xing Hospital, Capital Medical University
Beijing Haidian Hospital
Beijing Luhe Hospital
Beijing Aerospace General Hospital
General Hospital of Beijing PLA Military Region
Beijing Pinggu District Hospital
Beijing Huairou Hospital
Beijing Shuyi Hospital
People's Hospital of Beijing Daxing District
The 263 Hospital of PLA
Beijing Fangshan District Liangxiang Hospital
Peking University Aerospace Centre Hospital
KaiLuan General Hospital
Beijing Renhe Hospital

Investigators

  • Study Chair: Wen-Zhi Wang, professor, Beijing Neurosurgical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 26, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D141100000114003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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