Mechanism and Outcome of Acute Ischemic Stroke in Cancer Patients
NCT ID: NCT04195048
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
160 participants
OBSERVATIONAL
2018-11-01
2019-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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:
1. Detailed History taking of previous cerebrovascular insults and cancer diagnosis onset and therapies.
2. 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
3. Physical and neurological examination.
4. 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.
5. For all patients in the prospective group the duration and type of chemotherapy, dose of radiotherapy was recorded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Risk factors: modifiable and unmodifiable risk factors
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Risk factors
Risk factors: modifiable and unmodifiable risk factors
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 80 control patient with ischemic storke without cancer
Exclusion Criteria
* 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.
25 Years
89 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mansoura University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed Esmael
Assistant Prof of Neurology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Esmael M Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Prof of Neurology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mansoura University Hospital 9
Identifier Type: -
Identifier Source: org_study_id