Ischemic StrokeNCT04195048
Mechanism and Outcome of Acute Ischemic Stroke in Cancer Patients
An observational study of Ischemic Stroke and Cancer, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Cancer
- What is being tested?
- Risk factors
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke, Cancer
- Being tested
- Risk factors
- Keywords
- Ischemic Stroke, Cancer
- Medical subject headings
- Ischemic Stroke, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factorsOther
Risk factors: modifiable and unmodifiable risk factors
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with acute ischemic stroke | Eighty patients previously or currently suffering from manifest cancer on or not on cancer treatment who developed stroke Receives: Other: Risk factors | |
| Control patients with acute ischemic stroke without cancer | Eighty patients with acute ischemic stroke without cancer Receives: Other: Risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Nov 2018
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195048
- Sponsor's protocol ID
- Mansoura University Hospital 9
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism and Outcome of Acute Ischemic Stroke in Cancer Patients
- ClinicalTrials.gov ID
- NCT04195048
- Acronym / sponsor ID
- Mansoura University Hospital 9
- Conditions
- Ischemic Stroke, Cancer
- Keywords
- Ischemic Stroke, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with acute ischemic stroke | – | Other: Risk factorsEighty patients previously or currently suffering from manifest cancer on or not on cancer treatment who developed stroke |
| Control patients with acute ischemic stroke without cancer | – | Other: Risk factorsEighty patients with acute ischemic stroke without cancer |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factorsRisk factors: modifiable and unmodifiable risk factors | Other | Cancer patients with acute ischemic stroke, Control patients with acute ischemic stroke without cancer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Cancer, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.