Stroke, IschemicNCT04672148
Prognostic Factors and Mortality in Older Stroke Patients With Mechanical Thrombectomy
An observational study of Stroke, Ischemic, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The study focus on the elderly patient (older than 80 years of age) who had acute ischemic stroke and received mechanical thrombectomy. The investigators analyze different factors in the stage of before, between, after procedure and trying to figure out if there is any difference between the 30-day-mortality group… Read more about this study
- Who is it for?
- Ages 80 to 110 years
- Conditions the study is for
- Stroke, Ischemic
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2020to 11 Dec 2020
- 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 80 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 1. elderly (older than 80 years old) 2. acute ischemic stroke in anterior circulation 3. NIHSS more than 8
Who may be able to join
- elderly (older than 80 years old)
- acute ischemic stroke in anterior circulation
- NIHSS more than 8
Who cannot join
- posterior infarction
- ASPECT score less than 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Factors in Disease Progression and Mortality Risk in the Older Stroke Patients With Mechanical Thrombectomy
The study focus on the elderly patient (older than 80 years of age) who had acute ischemic stroke and received mechanical thrombectomy. The investigators analyze different factors in the stage of before, between, after procedure and trying to figure out if there is any difference between the 30-day-mortality group versus non-30-day-mortality group.
Read the detailed description
With the constant improvements in health care, standard of living and the decrease birth rate, the percentage of the elderly population ( above 80 years old) is expected to double in Taiwan by the year 2044, according to data from the National Development Council. Consequently with the increase in the proportion of senior citizens, there will be an surge number of patient suffering from cardiovascular and cerebrovascular diseases, most importantly acute ischemic stroke. In recent years, mechanical thrombectomy has become the gold standard in the treatment for acute stroke patients, however, many studies have excluded the patients above the age of 80 years old as the benefits of the procedure have been very controversial and there is no clear evidence proving favorable a outcome. There are a few studies which state that though elderly patients had higher risk of complications when receiving mechanical thrombectomy as compared to younger patients, the prognosis was still superior to those didn't receive any intervention. Previous studies put more emphasis on the overall prognosis, morbidity and mortality rate, they didn't focused on the cause of mortality.
The study focuses on analyzing of the cause of mortality and whether there is a significant difference between 30-day-mortality group versus non-30-day-mortality group.
- Conditions
- Stroke, Ischemic
- Keywords
- Thrombectomy,acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Patient who died in the 30 days after receiving mechanical thrombectomy, no matter the mortality cause | |
| B | Non-30-day-mortality group after receiving mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days mortality
Patient who died in the 30 days after receiving mechanical thrombectomy
Measured: 30 days
Secondary outcomes (1)
The cause of mortality
Analyse the main cause of mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Dec 2020
- Primary completion5 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szu-Hsiang Peng, MD, Principal investigator, FEMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672148
- Sponsor's protocol ID
- 109125-E
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Disease Progression and Mortality Risk in the Older Stroke Patients With Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT04672148
- Acronym / sponsor ID
- 109125-E
- Conditions
- Stroke, Ischemic
- Keywords
- Thrombectomy,acute ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 17 Dec 2020 (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.
The study focus on the elderly patient (older than 80 years of age) who had acute ischemic stroke and received mechanical thrombectomy. The investigators analyze different factors in the stage of before, between, after procedure and trying to figure out if there is any difference between the 30-day-mortality group versus non-30-day-mortality group.
Detailed description
With the constant improvements in health care, standard of living and the decrease birth rate, the percentage of the elderly population ( above 80 years old) is expected to double in Taiwan by the year 2044, according to data from the National Development Council. Consequently with the increase in the proportion of senior citizens, there will be an surge number of patient suffering from cardiovascular and cerebrovascular diseases, most importantly acute ischemic stroke. In recent years, mechanical thrombectomy has become the gold standard in the treatment for acute stroke patients, however, many studies have excluded the patients above the age of 80 years old as the benefits of the procedure have been very controversial and there is no clear evidence proving favorable a outcome. There are a few studies which state that though elderly patients had higher risk of complications when receiving mechanical thrombectomy as compared to younger patients, the prognosis was still superior to those didn't receive any intervention. Previous studies put more emphasis on the overall prognosis, morbidity and mortality rate, they didn't focused on the cause of mortality.
The study focuses on analyzing of the cause of mortality and whether there is a significant difference between 30-day-mortality group versus non-30-day-mortality group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patient who died in the 30 days after receiving mechanical thrombectomy, no matter the mortality cause |
| B | – | –Non-30-day-mortality group after receiving mechanical thrombectomy |
Who may qualify
- Ages
- 80 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 1. elderly (older than 80 years old) 2. acute ischemic stroke in anterior circulation 3. NIHSS more than 8
Key inclusion criteria (3 listed)
- elderly (older than 80 years old)
- acute ischemic stroke in anterior circulation
- NIHSS more than 8
Key exclusion criteria (2 listed)
- posterior infarction
- ASPECT score less than 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30 days mortality
Time frame: 30 days
Patient who died in the 30 days after receiving mechanical thrombectomy
1 secondary outcome
The cause of mortality
Time frame: 30 days
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 28 Feb 2024.
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Szu-Hsiang Peng, MD principal investigator
FEMH
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 Stroke, Ischemic, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 28 Feb 2024. 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 Taiwan. 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?
30 days mortality (time frame: 30 days). 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 28 Feb 2024.