Ischemic StrokeNCT04771468
"Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".
An observational study of Ischemic Stroke, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- MOSTCAREup Monitoring and Ecocardiography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 31 Dec 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted for acute ischemic stroke
Who may be able to join
- Adult patients aged ≥ 18 years.
- Acute supratentorial or carotid stroke. Exclusion criteria
- 1. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions:
- Intraoperative technical limitations limiting or impeding the arterial re-opening
- Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milano, 20089
Antonio Messina, MD, +390282241, antonio.messina@humanitas.it
Antonio Messina, MD, +3902822414131, mess81rc@gmail.com
About this study
Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.
- Conditions
- Ischemic Stroke
- Being tested
- MOSTCAREup Monitoring, Ecocardiography
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSTCAREup MonitoringDevice
The patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access).
EcocardiographyDevice
Echocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Sovratentorial ischemic stroke | Not described Receives: Device: MOSTCAREup Monitoring; Device: Ecocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output measurement
Changes of cardiac output of the enrolled patients before and after clot removal.
Measured: Up to 6 hours after clot removal
Arterial elastance measurement
Changes of arterial elastance of the enrolled patients before and after clot removal.
Measured: Up to 6 hours after clot removal
Arterial blood pressure measurement
Changes of arterial blood pressure of the enrolled patients before and after clot removal.
Measured: Up to 6 hours after clot removal
Heart rate variability measurement
Changes of heart rate variability of the enrolled patients before and after clot removal.
Measured: Up to 6 hours after clot removal
Secondary outcomes (4)
Transthoracic echocardiography
Ejection Fraction measurement
Measured: at the admission
Transthoracic Echocardiography
wave E assessment
Measured: up to 3 weeks after clot removal
Transthoracic Echocardiography
wave A assessment
Measured: up to 3 weeks after clot removal
Transthoracic Echocardiography
wave e' assessment
Measured: up to 3 weeks after clot removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Policlinico San Martino
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771468
- Sponsor's protocol ID
- STROKE_EMO
- Status last verified
- Sep 2021
- First submitted
- 6 Jan 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Hemodynamic Changes During Endovascular Revascularization for Acute Stroke. An Observational Study".
- ClinicalTrials.gov ID
- NCT04771468
- Acronym / sponsor ID
- STROKE_EMO
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Collaborators
- Ospedale Policlinico San Martino
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Feb 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.
Neurocardiology is an emerging specialty that addresses the interaction between the brain and the heart, i.e. the effects of cardiac injury on the brain, and the effects of brain injury on the heart. Accumulating clinical and experimental evidence suggests a causal relationship between brain damage and heart dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sovratentorial ischemic stroke | – | Device: MOSTCAREup Monitoring, Device: Ecocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for acute ischemic stroke
Key inclusion criteria (5 listed)
- Adult patients aged ≥ 18 years.
- Acute supratentorial or carotid stroke. Exclusion criteria
- 1. Invasive arterial signal unsuitable to obtain hemodynamic data. 2. Emergency neurosurgery needed before intra-arterial treatment. 3. Once enrolled, the patient can be excluded from the study because of one of the following intraoperative conditions:
- Intraoperative technical limitations limiting or impeding the arterial re-opening
- Persistent low quality of the arterial signal. After positioning the patient and zeroing the arterial signal, the arterial waveform is checked for quality by means of a square-wave test and optimized in the case of the occurrence of under or over-damping.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MOSTCAREup MonitoringThe patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access). | Device | Sovratentorial ischemic stroke |
| EcocardiographyEchocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure. | Device | Sovratentorial ischemic stroke |
Primary outcome
Cardiac output measurement
Time frame: Up to 6 hours after clot removal
Changes of cardiac output of the enrolled patients before and after clot removal.
Arterial elastance measurement
Time frame: Up to 6 hours after clot removal
Changes of arterial elastance of the enrolled patients before and after clot removal.
Arterial blood pressure measurement
Time frame: Up to 6 hours after clot removal
Changes of arterial blood pressure of the enrolled patients before and after clot removal.
Heart rate variability measurement
Time frame: Up to 6 hours after clot removal
Changes of heart rate variability of the enrolled patients before and after clot removal.
4 secondary outcomes
Transthoracic echocardiography
Time frame: at the admission
Transthoracic Echocardiography
Time frame: up to 3 weeks after clot removal
Transthoracic Echocardiography
Time frame: up to 3 weeks after clot removal
Transthoracic Echocardiography
Time frame: up to 3 weeks after clot removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
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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.
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, run by Humanitas Clinical and Research Center at 1 site in Italy.
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 0 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 2 Sep 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output measurement (time frame: Up to 6 hours after clot removal). The study lists 4 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 2 Sep 2021.