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Completed

NCT Number: NCT04195048

Mechanism and Outcome of Acute Ischemic Stroke in Cancer Patients

Stroke is a part of circulatory diseases which are the primary cause of death in Egypt. It accounts 14% of all deaths thus ranks the 2nd after ischemic heart disease. Cancer accounts 9% of population mortality in Egypt. Nearly 108,600 Egyptians newly diagnosed with cancer each year. The interrelationship between stroke and cancer is complex. Cancer may directly or indirectly lead to stroke via: hypercoagulability, nonbacterial thrombotic endocarditis (NBTE), direct tumor compression of blood vessels or treatment-related effects which potentiate stroke.

The risk of ischemic stroke after chemotherapy is largely increased by the use of certain types of chemotherapy not only by cancer histologic type. Brain infarction usually a subsequent complication appears sometimes shortly after chemotherapy. Chronic radiation vasculopathy that affects medium and large intra- and extra-cranial arteries is characterized by increasing rates of hemodynamic significant stenosis with time after radiotherapy.

The study aims to clarify the relation between cancer and its treatment with ischemic stroke by discussing the different mechanisms by which a vascular insult happen causing neurological deficit. The study provides more information about cancer patients with higher risk to develop ischemic stroke more than other patients by identifying co morbidities and dosage of cancer treatment that causes cerebrovascular insults.

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Key information

Age range

25 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

  • Retrospective study was conducted on patients diagnosed with cancer receiving chemotherapy or radiotherapy to evaluate the relation between cancer or cancer therapies and ischemic stroke development.
  • Patients had been recruited from the oncology center, nuclear medicine department and neurology department in Mansoura University and private centers.

After obtaining informed consent, patients are subjected to the following:

  • Detailed History taking of previous cerebrovascular insults and cancer diagnosis onset and therapies.
  • Determination of major cerebrovascular risk factors as :
  • Hypertension: which is diagnosed when a patient had received antihypertensive treatment or when hypertension is diagnosed during the hospital stay by repeated detection of blood pressure of 140/90 mm Hg .
  • Diabetes mellitus (DM): diagnosis based on history of DM with or without current treatment or random blood glucose is 200mg/dl or higher.
  • Hypercholesterolemia: diagnosis based on history of hypercholesterolemia with current treatment or serum cholesterol level >220mg/dl.
  • Smoking: is coded when the patient is a current smoker or an ex-smoker within 5 years.
  • Cardiac abnormality
  • Physical and neurological examination.
  • Investigations:
  • Laboratory investigations as complete blood count, lipid profile, coagulation profile, CRP , D dimer .
  • Radiological investigations: MRI brain to detect vascular abnormalities that may be associated with cancer such as: lacunar infarction , white matter changes and microbleeds.
  • For all patients in the prospective group the duration and type of chemotherapy, dose of radiotherapy was recorded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 80 patients previously or currently suffering from manifest cancer on or not on cancer treatment who developed stroke
  • 80 control patient with ischemic storke without cancer

Exclusion criteria

  • Patients developed cerebrovascular insults prior to the onset of cancer
  • Cancer patients with symptoms mimic stroke.
  • Cancer patients with focal neurological deficit due to direct effect of malignant tumor.
  • Patients missed their follow up.
  • Patients with traditional cerebrovascular risk factors such as (hypertension, hyperlipidemia, diabetes and atrial fibrillation) prior to cancer diagnosis.

Treatment and study plan

risk factors

Other

Risk factors: modifiable and unmodifiable risk factors

Primary outcomes

  1. Modified Rankin Scale

    Time frame: 6 months

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 11, 2019
Registry last updated
Dec 11, 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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