- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Detailed Description
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt, 35516
- Mansoura University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cancer patients with acute ischemic stroke
Eighty patients previously or currently suffering from manifest cancer on or not on cancer treatment who developed stroke
|
Risk factors: modifiable and unmodifiable risk factors
|
Control patients with acute ischemic stroke without cancer
Eighty patients with acute ischemic stroke without cancer
|
Risk factors: modifiable and unmodifiable risk factors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mansoura University Hospital 9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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