Identification the Cause of Cerebral Infarction in Patients With Cancer

NCT02212496 | Completed

• 1 other identifier: 2014-07-136
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cryptogenic Embolic Stroke; Active Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of intravascular thrombosis on infarct volume

  Within one week after enrollment

• Impact of intravascular thrombosis on survival

  Till the event of death occurs in enrolled patients

Study Arms (2)

Cancer-associated stroke

Cryptogenic embolic stroke with active cancer

Cryptogenic embolic stroke

Cryptogenic embolic stroke without active cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Embolic stroke of undetermined source with or without cancer, admitted to Samsung Medical Center (tertiary hospital with comprehensive stroke and cancer center)

You may qualify if:

• 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

You may not qualify if:

• Subjects with single subcortical infarction
• Subjects with primary brain tumor
• Inability to perform comprehensive studies
• Refusal or withdrawal of the consent

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

Related Publications (1)

• Ha J, Lee MJ, Kim SJ, Park BY, Park H, Cho S, Chung JW, Seo WK, Kim GM, Bang OY, Chung CS. Prevalence and Impact of Venous and Arterial Thromboembolism in Patients With Embolic Stroke of Undetermined Source With or Without Active Cancer. J Am Heart Assoc. 2019 Nov 5;8(21):e013215. doi: 10.1161/JAHA.119.013215. Epub 2019 Oct 23.

  PMID: 31640456 DERIVED

Study Officials

• Chin-Sang Chung, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

KR (1)