Ischemic StrokeHEROES-CATNCT05871528
Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke
An observational study of Ischemic Stroke and Intracranial Hemorrhages, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Introduction Remote cerebral hemorrhage following reperfusion treatment in ischemic stroke is rare (1.3-3.7% of all treated strokes) and is associated with worse functional and vital prognosis. Multicenter observational studies suggest that amyloid angiopathy may be one of the main risk factors for remote hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 102 years
- Conditions the study is for
- Ischemic Stroke, Intracranial Hemorrhages, Hemorrhagic Transformation Stroke
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 1 May 2025
- 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 102 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study outlines a four-step process to identify and select cases for a study on remote hemorrhages with or without local hemorrhagic transformation. The first step is to identify cases by evaluating control neuroimaging, and if there are doubts, investigators can seek consensus decision-making. The second step is to select four controls for each case, two without hemorrhagic transformation and two with type 2 hemorrhagic transformation. The third step involves completing the CICAT registry form and additional variables, some of which are optional. The fourth and final step is to conduct telephone follow-up at 3, 12, and 24 months to collect variables of interest in relation to the study's objectives.
Who may be able to join
- Patients who meet the criteria for being a case (remote hemorrhage) or control according to the definition of Heidelberg hemorrhagic transformations
- Age 18 or older
- Definite diagnosis of ischemic stroke (intracranial large vessel occlusion, compatible lesion on neuroimaging)
- Administration of a fibrinolytic drug associated or not with endovascular therapy (intravenous or local)
- Availability of a control brain imaging before the first 36 hours from reperfusion treatment.
Who cannot join
- Lack of basic data (age, sex, follow-up neuroimaging, contact phone number for follow-up).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia
Luis Prats-Sanchez, PhD, +34935565986, lpratss@santpau.cat
+34935565986
About this study
Official title: HEROES Registry: Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke in Catalonia
Introduction Remote cerebral hemorrhage following reperfusion treatment in ischemic stroke is rare (1.3-3.7% of all treated strokes) and is associated with worse functional and vital prognosis. Multicenter observational studies suggest that amyloid angiopathy may be one of the main risk factors for remote hemorrhage. Currently, it is unknown what happens to those patients with remote hemorrhage beyond 3 months of follow-up in terms of risk/benefit balance when receiving antiplatelet or anticoagulant therapy, as well as from a cognitive point of view. Considering an analogy with amyloid angiopathy, the hypothesis is that those patients with remote hemorrhage have a higher risk of intracranial hemorrhage during follow-up when receiving stroke secondary prevention, and will also present greater cognitive deterioration during long-term follow-up.
Main Objectives
Read more
- To explore the frequency and risk factors for intracranial hemorrhage during follow-up of patients with remote cerebral hemorrhage.
- To explore the frequency and progression of cognitive deterioration during follow-up in patients with remote cerebral hemorrhage.
Methodology Observational, prospective, multicenter registry with a population-based case-control design of consecutive patients with remote hemorrhage following reperfusion therapy in acute ischemic stroke. Inclusion criteria: Diagnosis of ischemic stroke with age greater than or equal to 18 years who has remote cerebral hemorrhage after receiving reperfusion therapy in the acute phase. Exclusion criteria: Lack of basic data (age, sex, neuroimaging data) or telephone for follow-up. The cases will be those patients with remote hemorrhage. For each case included, 4 consecutive controls will be included (2 with local parenchymal hemorrhagic transformation and 2 without hemorrhagic transformation). The data will be filled out within the (Codi Ictus de CATalunya) CICAT registry form (currently mandatory in all stroke centers in Catalonia) to which additional variables will be added. Telephone follow-up will be conducted at 3, 12, and 24 months.
Main study variable:
- Any type of spontaneous or traumatic intracranial hemorrhage during a 24-month follow-up.
- Score on the "Short Informant Questionnaire" scale (a validated 17-question questionnaire to be conducted over the phone, where a score higher than 57 points indicates cognitive impairment).
Expected sample size during a 2-year recruitment period: 105-300 patients (considering the participating centers to date).
Additional information. This study is endorsed by the "Pla Director de la Malaltia Vascular Cerebral" in Catalonia.
Participating Centers. Participation offers have been sent to the 28 hospitals in the hospital network of Catalonia with the capacity to administer intravenous fibrinolysis. Positive responses have been received from 13 of them so far. In case the project is accepted by the (Comité Ético de Investigación Clínica) CEIC Sant Pau, the centers that have not responded will be contacted again to obtain their participation.
- Keywords
- Ischemic stroke, Thrombolysis, Hemorrhagic transformation stroke, Secondary prevention
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
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 |
|---|---|---|
| No hemorrhagic transformation | Patients with ischemic stroke treated with intravenous thrombolysis and no hemorrhagic transformation (IH1 or IH2 are allowed) | |
| Local hemorragic transformation | Patients with ischemic stroke treated with intravenous thrombolysis and hemorrhagic transformation PH1 or PH2 | |
| Remote hemorrhage | Patients with ischemic stroke treated with intravenous thrombolysis and remote hemorrhage in areas without evident ischemia (rPH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the frequency and risk factors of intracranial hemorrhage during follow-up in patients with remote cerebral hemorrhage
Describe the frequency, rate and adjusted hazard ratio
Measured: 24 months
Secondary outcomes (5)
Explore the frequency of ischemic stroke, intracerebral hemorrhage, intracranial hemorrhage, and any cerebrovascular event in patients with remote cerebral hemorrhage.
Describe the frequency, rate and adjusted hazard ratio
Measured: 24 months
Investigate the net benefit of preventive treatment in patients with remote cerebral hemorrhage (composite of ischemic stroke and intracranial hemorrhage).
Evaluate the rate and adjusted hazard ratio of ischemic and hemorrhagic events
Measured: 24 months
Explore the socio-functional status of patients with remote cerebral hemorrhage using the modified Rankin Scale during follow-up.
Describe the proportion of patients with favorable functional outcome measured with modified Rankin Scale (favorable is the score is 0-2)
Measured: 24 months
Explore vascular mortality and overall mortality in patients with remote cerebral hemorrhage during follow-up.
Describe the frequency, rate and adjusted hazard ratio
Measured: 24 months
Explore cognitive impairment follow-up
IQCODE brief test >56 points
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 May 2021
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital del Mar, Hospital de Granollers, Hospital Arnau de Vilanova, Parc Taulí Hospital Universitari, Consorci Sanitari del Garraf, Hospital de Sant Joan Despí Moisès Broggi, Hospital Clinic of Barcelona, University Hospital of Girona Dr. Josep Trueta, Hospital Universitari de Bellvitge, Hospital Vall d'Hebron, Agència de Qualitat i Avaluació Sanitàries
- Responsible party
- Sponsor
- Investigators
- Luis Prats Sanchez, MD PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871528
- Sponsor's protocol ID
- IIBSP-HER-2020-79
- Acronym
- HEROES-CAT
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 23 May 2023
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEROES Registry: Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke in Catalonia
- ClinicalTrials.gov ID
- NCT05871528
- Acronym / sponsor ID
- HEROES-CAT / IIBSP-HER-2020-79
- Keywords
- Ischemic stroke, Thrombolysis, Hemorrhagic transformation stroke, Secondary prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Hospital del Mar, Hospital de Granollers, Hospital Arnau de Vilanova, Parc Taulí Hospital Universitari, Consorci Sanitari del Garraf, Hospital de Sant Joan Despí Moisès Broggi, Hospital Clinic of Barcelona, University Hospital of Girona Dr. Josep Trueta, Hospital Universitari de Bellvitge, Hospital Vall d'Hebron, Agència de Qualitat i Avaluació Sanitàries
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 23 May 2023 (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.
Introduction Remote cerebral hemorrhage following reperfusion treatment in ischemic stroke is rare (1.3-3.7% of all treated strokes) and is associated with worse functional and vital prognosis. Multicenter observational studies suggest that amyloid angiopathy may be one of the main risk factors for remote hemorrhage. Currently, it is unknown what happens to those patients with remote hemorrhage beyond 3 months of follow-up in terms of risk/benefit balance when receiving antiplatelet or anticoagulant therapy, as well as from a cognitive point of view. Considering an analogy with amyloid angiopathy, the hypothesis is that those patients with remote hemorrhage have a higher risk of intracranial hemorrhage during follow-up when receiving stroke secondary prevention, and will also present greater cognitive deterioration during long-term follow-up.
Main Objectives
- To explore the frequency and risk factors for intracranial hemorrhage during follow-up of patients with remote cerebral hemorrhage.
- To explore the frequency and progression of cognitive deterioration during follow-up in patients with remote cerebral hemorrhage.
Methodology Observational, prospective, multicenter registry with a population-based case-control design of consecutive patients with remote hemorrhage following reperfusion therapy in acute ischemic stroke. Inclusion criteria: Diagnosis of ischemic stroke with age greater than or equal to 18 years who has remote cerebral hemorrhage after receiving reperfusion therapy in the acute phase. Exclusion criteria: Lack of basic data (age, sex, neuroimaging data) or telephone for follow-up. The cases will be those patients with remote hemorrhage. For each case included, 4 consecutive controls will be included (2 with local parenchymal hemorrhagic transformation and 2 without hemorrhagic transformation). The data will be filled out within the (Codi Ictus de CATalunya) CICAT registry form (currently mandatory in all stroke centers in Catalonia) to which additional variables will be added. Telephone follow-up will be conducted at 3, 12, and 24 months.
Main study variable:
- Any type of spontaneous or traumatic intracranial hemorrhage during a 24-month follow-up.
- Score on the "Short Informant Questionnaire" scale (a validated 17-question questionnaire to be conducted over the phone, where a score higher than 57 points indicates cognitive impairment).
Expected sample size during a 2-year recruitment period: 105-300 patients (considering the participating centers to date).
Additional information. This study is endorsed by the "Pla Director de la Malaltia Vascular Cerebral" in Catalonia.
Participating Centers. Participation offers have been sent to the 28 hospitals in the hospital network of Catalonia with the capacity to administer intravenous fibrinolysis. Positive responses have been received from 13 of them so far. In case the project is accepted by the (Comité Ético de Investigación Clínica) CEIC Sant Pau, the centers that have not responded will be contacted again to obtain their participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No hemorrhagic transformation | – | –Patients with ischemic stroke treated with intravenous thrombolysis and no hemorrhagic transformation (IH1 or IH2 are allowed) |
| Local hemorragic transformation | – | –Patients with ischemic stroke treated with intravenous thrombolysis and hemorrhagic transformation PH1 or PH2 |
| Remote hemorrhage | – | –Patients with ischemic stroke treated with intravenous thrombolysis and remote hemorrhage in areas without evident ischemia (rPH) |
Who may qualify
- Ages
- 18 to 102 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study outlines a four-step process to identify and select cases for a study on remote hemorrhages with or without local hemorrhagic transformation. The first step is to identify cases by evaluating control neuroimaging, and if there are doubts, investigators can seek consensus decision-making. The second step is to select four controls for each case, two without hemorrhagic transformation and two with type 2 hemorrhagic transformation. The third step involves completing the CICAT registry form and additional variables, some of which are optional. The fourth and final step is to conduct telephone follow-up at 3, 12, and 24 months to collect variables of interest in relation to the study's objectives.
Key inclusion criteria (5 listed)
- Patients who meet the criteria for being a case (remote hemorrhage) or control according to the definition of Heidelberg hemorrhagic transformations
- Age 18 or older
- Definite diagnosis of ischemic stroke (intracranial large vessel occlusion, compatible lesion on neuroimaging)
- Administration of a fibrinolytic drug associated or not with endovascular therapy (intravenous or local)
- Availability of a control brain imaging before the first 36 hours from reperfusion treatment.
Key exclusion criteria (1 listed)
- Lack of basic data (age, sex, follow-up neuroimaging, contact phone number for follow-up).
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
Explore the frequency and risk factors of intracranial hemorrhage during follow-up in patients with remote cerebral hemorrhage
Time frame: 24 months
Describe the frequency, rate and adjusted hazard ratio
5 secondary outcomes
Explore the frequency of ischemic stroke, intracerebral hemorrhage, intracranial hemorrhage, and any cerebrovascular event in patients with remote cerebral hemorrhage.
Time frame: 24 months
Investigate the net benefit of preventive treatment in patients with remote cerebral hemorrhage (composite of ischemic stroke and intracranial hemorrhage).
Time frame: 24 months
Explore the socio-functional status of patients with remote cerebral hemorrhage using the modified Rankin Scale during follow-up.
Time frame: 24 months
Explore vascular mortality and overall mortality in patients with remote cerebral hemorrhage during follow-up.
Time frame: 24 months
Explore cognitive impairment follow-up
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- 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.
Luis Prats Sanchez, MD PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Intracranial Hemorrhages, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 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 23 May 2023. 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 Spain. 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?
Contact Luis Prats Sanchez, MD PhD (+34935565986, lpratss@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the frequency and risk factors of intracranial hemorrhage during follow-up in patients with remote cerebral hemorrhage (time frame: 24 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 23 May 2023.