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Etiology and Prognostic Risk Factors of Intracerebral Hemorrhage in Beijing

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02350010
Enrollment
1500
Registered
2015-01-29
Start date
2015-01-31
Completion date
2017-03-31
Last updated
2015-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

Etiology, Prognostic risk factors, Intracerebral Hemorrhage, non-invasive imaging, CT angiography

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.

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.

Interventions

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
one-year functional outcome and mortality of Intracerebral hemorrhage.one yearGood functional outcome was defined as modified Rankin Scale score (mRS) ≤2.

Countries

China

Contacts

Primary ContactWen-Zhi Wang, professor
qgnfbwwz@163.com0086-010-65112838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026