Stroke, IschemicCOLISEUMNCT04882657
Collateral Circulation in Acute Ischemic Stroke With Large Vessel Occlusion
An observational study of Stroke, Ischemic and Stroke, Acute, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke, Acute, Collateral Circulation, Any Site
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke and a large-vessel intracranial occlusion.
Who may be able to join
- Patients with acute ischemic stroke.
- Large vessel occlusion of an intracranial internal artery: M1, M2 or TICA. (terminal intracranial carotid artery), as demonstrated by CTA.
- CTA performed within the first 24 hours after stroke onset. Patients with wake-up stroke are included.
- A previous modified Rankin Scale score of 0 to 3.
- The patient or a legal representative signs a written consent to participate.
Who cannot join
- More than 24 hours from last been known to be well.
- Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
- Age below 18 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Collateral Circulation ("Collaterome") in Acute Ischemic Stroke With Large Vessel Occlusion: A Study of Clinical, Radiological, Plasma and Genetic Factors.
Prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed.
Read the detailed description
Introduction. In patients with an acute ischemic stroke due to a large-vessel intracranial occlusion (LVO), the status of the colateral circulation (CC) is related to clinical outcome and to the success of mechanical thrombectomy. However, CC is highly variable from patient to patient.
Methods. An observational, prospective, multicenter study of 700 consecutive patients with acute ischemic stroke and a LVO. Factors to be evaluated: 1) Modifiable: Vascular risk factors, blood analysis, prior medications, vital constants (with emphasis on continuous blood pressure monitoring), head position, metrics (time to admission, Computed tomography (CT), groin puncture, end of procedure), 2) Non-modifiable: age, sex, completeness of Circle of Willis, etiology, type of mechanical thrombectomy, plasma biomarkers, genetic/epigenetic factors (a discovery phase with GWAs study and a replication phase). CC grade will be assessed by the ASITN/SIR collateral score from CT-angiography (CTA) and the Digital substraction angiography (DSA, when performed). Statistics: bivariate analyses and a logistic regression to predict CC grade (poor versus good) and CC persistence comparing CTA with DSA (4 possibilities: poor-poor, poor-good, good-poor, good-good).
Expected results. Our study may find markers of the CC status, facilitate the design of clinical trials to improve CC grade, may find new therapeutic targets and new treatments to enhance the beneficial effects of mechanical thrombectomy.
- Keywords
- Collateral Circulation, Ischemic Stroke, Large Vessel Occlusion
- Medical subject headings
- Ischemic Stroke, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Collateral Circulation grade
Measured: Trough the acute phase of stroke, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Sep 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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Complejo Hospitalario Universitario de Albacete, Hospital de Cruces, Hospital Clínico Universitario de Valladolid, Hospitales Universitarios Virgen del Rocío, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario La Paz, Hospital del Mar, Hospital Arnau de Vilanova, Complexo Hospitalario Universitario de A Coruña, Red de Enfermedades Vasculares Cerebrales INVICTUS PLUS (Rd1600190024)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882657
- Sponsor's protocol ID
- IIBSP-COL-2019-64
- Acronym
- COLISEUM
- Status last verified
- May 2021
- First submitted
- 5 Dec 2019
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collateral Circulation ("Collaterome") in Acute Ischemic Stroke With Large Vessel Occlusion: A Study of Clinical, Radiological, Plasma and Genetic Factors.
- ClinicalTrials.gov ID
- NCT04882657
- Acronym / sponsor ID
- COLISEUM / IIBSP-COL-2019-64
- Keywords
- Collateral Circulation, Ischemic Stroke, Large Vessel Occlusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Complejo Hospitalario Universitario de Albacete, Hospital de Cruces, Hospital Clínico Universitario de Valladolid, Hospitales Universitarios Virgen del Rocío, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario La Paz, Hospital del Mar, Hospital Arnau de Vilanova, Complexo Hospitalario Universitario de A Coruña, Red de Enfermedades Vasculares Cerebrales INVICTUS PLUS (Rd1600190024)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 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.
Prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed.
Detailed description
Introduction. In patients with an acute ischemic stroke due to a large-vessel intracranial occlusion (LVO), the status of the colateral circulation (CC) is related to clinical outcome and to the success of mechanical thrombectomy. However, CC is highly variable from patient to patient.
Methods. An observational, prospective, multicenter study of 700 consecutive patients with acute ischemic stroke and a LVO. Factors to be evaluated: 1) Modifiable: Vascular risk factors, blood analysis, prior medications, vital constants (with emphasis on continuous blood pressure monitoring), head position, metrics (time to admission, Computed tomography (CT), groin puncture, end of procedure), 2) Non-modifiable: age, sex, completeness of Circle of Willis, etiology, type of mechanical thrombectomy, plasma biomarkers, genetic/epigenetic factors (a discovery phase with GWAs study and a replication phase). CC grade will be assessed by the ASITN/SIR collateral score from CT-angiography (CTA) and the Digital substraction angiography (DSA, when performed). Statistics: bivariate analyses and a logistic regression to predict CC grade (poor versus good) and CC persistence comparing CTA with DSA (4 possibilities: poor-poor, poor-good, good-poor, good-good).
Expected results. Our study may find markers of the CC status, facilitate the design of clinical trials to improve CC grade, may find new therapeutic targets and new treatments to enhance the beneficial effects of mechanical thrombectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke and a large-vessel intracranial occlusion.
Key inclusion criteria (5 listed)
- Patients with acute ischemic stroke.
- Large vessel occlusion of an intracranial internal artery: M1, M2 or TICA. (terminal intracranial carotid artery), as demonstrated by CTA.
- CTA performed within the first 24 hours after stroke onset. Patients with wake-up stroke are included.
- A previous modified Rankin Scale score of 0 to 3.
- The patient or a legal representative signs a written consent to participate.
Key exclusion criteria (3 listed)
- More than 24 hours from last been known to be well.
- Occlusion of other arterial segments (vertebrobasilar circulation, A1, P1, M3, M4).
- Age below 18 years.
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
Collateral Circulation grade
Time frame: Trough the acute phase of stroke, an average of 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Stroke, Acute, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 3 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 12 May 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?
Contact Joan Martí-Fàbregas, MD, PhD (+34935565986, jmarti@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collateral Circulation grade (time frame: Trough the acute phase of stroke, an average of 24 hours). 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 12 May 2021.