Identification the Cause of Cerebral Infarction in Patients With Cancer

Active Cancer Clinical Trial

Official title:

Identification the Cause of Cerebral Infarction in Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212496
• Other study ID #: 2014-07-136
• Status: Completed
• Start date: August 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although there has been increasing interest in the association between cancer and cerebrovascular disease, the underlying pathophysiology of stroke in cancer patients is still not fully understood. The aim of this study is to investigate the stroke mechanisms in patients with cancer-associated stroke.

Description:

Patients with cryptogenic embolic stroke will be prospectively enrolled and categorized into two groups according to the presence of active cancer: cryptogenic embolic stroke with active cancer (cancer-associated stroke) vs. without active cancer (cryptogenic embolic stroke). All patients will undergo brain MRI/MRA, 12-lead electrocardiography, transthoracic and transesophageal echocardiography with injection of agitated saline, and 24-hour Holter and/or telemonitoring. Duplex ultrasonography to detect venous thrombosis of the lower extremity will also be performed in patients with a positive right-to-left shunt on echocardiography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with acute ischemic stroke who presented within 7 days from symptom onset

• Subjects who had embolic infarction outside the perforator territory revealed by diffusion-weighted imaging

• Subjects with undetermined cause of stroke despite of initial evaluation including electrocardiogram and brain imaging upon admission

• Subjects who performed brain magnetic resonance image (MRI) and MR angiography (MRA), cardiac work-ups (12-lead electrocardiography, transthoracic and/or transesophageal echocardiography with injection of agitated saline (or agitated saline transcranial Doppler monitoring), and 24-hour Holter and/or telemonitoring)

• Subjects with informed consent

Exclusion Criteria:

• Subjects with single subcortical infarction

• Subjects with primary brain tumor

• Inability to perform comprehensive studies

• Refusal or withdrawal of the consent

Related Conditions & MeSH terms

• Active Cancer
• Cerebral Infarction
• Cryptogenic Embolic Stroke
• Infarction

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients	Venous thromboembolism was investigated via Doppler sonography and/or computed tomography pulmonary angiography combined with venous phase CT angiography of the lower extremities. Microembolic signal was detected via transcranial Doppler sonography on symptomatic cerebral circulation	Within one week after enrollment
Secondary	Impact of intravascular thrombosis on infarct volume	Infarct volume was measured by diffusion-weighted MR imaging and apparent diffusion coefficient calculated from imaging data. Univariate and multivariate linear regression was performed in ESUS patients with cancer (adjusted for age, sex, overt DIC).	Within one week after enrollment
Secondary	Impact of intravascular thrombosis on survival	Survival time (in years) was measured by subtracting admission date from the date the patient had expired. Cox proportional hazard analysis was used to evaluate association between intravascular thrombosis and survival (adjusted for age, sex, NIHSS, presence of overt DIC, infarct volume, metastasis, and histologic type).	Till the event of death occurs in enrolled patients