Acute StrokeNCT04978181
The Prevalence and Associated Factors of Early Deterioration After Successful Recanalization in Acute Ischemic Stroke
An observational study of Acute Stroke, run by Assiut University.
Trial summary
stroke is a leading cause of morbidity and mortality worldwide. More than half (54.5%) of the 56.9 million deaths worldwide in 2106 were due to the top 10 causes. Ischemic heart disease and stroke are the world's biggest killers, accounting for a combined 15.2 million deaths in 2106. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Alteplase Injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admittedto Assiut University Hospitals within time window for thrombolysis or thrombectomy within one year are included
Who may be able to join
- Ischemic stroke of both sex.
- More than 08 years.
- Accepting all study requirements.
- within time window for thrombolysis or thrombectomy
- fulfilling criteria for thrombolysis or thrombectomy
Who cannot join
- (A)Absolute Contraindications :
- Intracerebral hemorrhage history or presence on imaging
- Time of onset more than 465 hours
- Blood pressure greater than 085/000 mm Hg
- Recent severe head trauma or neurosurgical intervention
- Coagulopathy (INR >067, thrombocytopenia, recent use of heparin or direct oral anticoagulants)
Show all 9Show fewer
- Endocarditis (infective)
- Aortic dissection (B)Potential Contraindications :
- 1.Seizure at onset 2.Noncompressible arterial puncture 3.Recent surgery 4.Gastrointestinal or genitourinary bleeding 5.Multiple cortical microbleeds (>00) 6. Large intracranial aneurysms or arteriovenous malformations 7.Recent transmural myocardial infarction 8. Small NIHSS with nondisabling stroke symptoms
About this study
Official title: The Prevalence and Associated Factors of Early Neurological Deterioration After Successful Recanalization Treatment in Patients With Acute Ischemic Stroke
stroke is a leading cause of morbidity and mortality worldwide. More than half (54.5%) of the 56.9 million deaths worldwide in 2106 were due to the top 10 causes.
Ischemic heart disease and stroke are the world's biggest killers, accounting for a combined 15.2 million deaths in 2106. These diseases have remained the leading causes of death globally in the last 15 years.
Read more
Recent clinical trials have shown that endo-vascular thrombectomy is an effective and safe recanalization modality for acute ischemic stroke patients .
Meta-analysis results show that endovascular treatment is associated with a high ratio of successful recanalization rate and a low rate of symptomatic hemorrhage .
Approximately 2.2-37.5% of patients with acute ischemic stroke might encounter early neurological deterioration (END).
Definition of END: An increase in NIHSS ≥4 or an increase in Ia of NIHSS ≥1 within 72 h after recanalization treatment.
- Conditions
- Acute Stroke
- Being tested
- Alteplase Injection
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteplase InjectionDrug
Also called thrombolysis
thrombolytic therapy for acute ischemic stroke in time window
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
Measured: 1 year
factors of deterioration
factors of deterioration
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ibrahim Aboelfath Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978181
- Sponsor's protocol ID
- recanalization deterioration
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Associated Factors of Early Neurological Deterioration After Successful Recanalization Treatment in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04978181
- Acronym / sponsor ID
- recanalization deterioration
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 27 Jul 2021 (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 leading cause of morbidity and mortality worldwide. More than half (54.5%) of the 56.9 million deaths worldwide in 2106 were due to the top 10 causes.
Ischemic heart disease and stroke are the world's biggest killers, accounting for a combined 15.2 million deaths in 2106. These diseases have remained the leading causes of death globally in the last 15 years.
Recent clinical trials have shown that endo-vascular thrombectomy is an effective and safe recanalization modality for acute ischemic stroke patients .
Meta-analysis results show that endovascular treatment is associated with a high ratio of successful recanalization rate and a low rate of symptomatic hemorrhage .
Approximately 2.2-37.5% of patients with acute ischemic stroke might encounter early neurological deterioration (END).
Definition of END: An increase in NIHSS ≥4 or an increase in Ia of NIHSS ≥1 within 72 h after recanalization treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admittedto Assiut University Hospitals within time window for thrombolysis or thrombectomy within one year are included
Key inclusion criteria (5 listed)
- Ischemic stroke of both sex.
- More than 08 years.
- Accepting all study requirements.
- within time window for thrombolysis or thrombectomy
- fulfilling criteria for thrombolysis or thrombectomy
Key exclusion criteria (9 listed)
- Intracerebral hemorrhage history or presence on imaging
- Time of onset more than 465 hours
- Blood pressure greater than 085/000 mm Hg
- Recent severe head trauma or neurosurgical intervention
- Coagulopathy (INR >067, thrombocytopenia, recent use of heparin or direct oral anticoagulants)
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 |
|---|---|---|
| Alteplase InjectionAlso: thrombolysisthrombolytic therapy for acute ischemic stroke in time window | Drug | – |
Primary outcome
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
Time frame: 1 year
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke
factors of deterioration
Time frame: 1 year
factors of deterioration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Assiut University.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Prevalence of early neurological deterioration after successful recanalization treatment in patients with acute ischemic stroke (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Jul 2021.