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Completed

NCT Number: NCT02212496

Identification the Cause of Cerebral Infarction in Patients With Cancer

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.

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Key information

Conditions

Cryptogenic Embolic Stroke Active Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of deep vein thrombosis and microembolic signal in cancer related stroke patients

    Time frame: Within one week after enrollment

    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

Secondary outcomes

  1. Impact of intravascular thrombosis on infarct volume

    Time frame: Within one week after enrollment

    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).

  2. Impact of intravascular thrombosis on survival

    Time frame: Till the event of death occurs in enrolled patients

    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).

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2014
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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