Clinical trial NCT02212496: Identification the Cause of Cerebral Infarction in Patients With Cancer
Official title: Identification the Cause of Cerebral Infarction in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cryptogenic Embolic Stroke
Active Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients
timeFrame: Within one week after enrollment
Secondary outcomes:
measure: Impact of intravascular thrombosis on infarct volume
timeFrame: Within one week after enrollment
measure: Impact of intravascular thrombosis on survival
timeFrame: Till the event of death occurs in enrolled patients
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Chin-Sang Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.