Transient Ischemic AttackLLETISNCT04524078
Lleida TIA Intervention Study
A study testing intensive integrated intervention care program in people with Transient Ischemic Attack, run by Institut de Recerca Biomèdica de Lleida.
Trial summary
Having a transient ischemic attack (TIA) or a minor stroke is a real risk factor not only for early recurrent stroke but also for major extracranial vascular events. Despite these warning events provide an opportunity for prevention usual post-discharge care of these subjects (mainly at primary care) is not associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack
- What is being tested?
- intensive integrated intervention care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 31 Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients with transient ischemic attack (reversible episode of neurological deficit of ischemic origin that resolved completely within 24 hours) or minor stroke (established neurological deficit of ischemic origin with US National Institutes of Health stroke scale [NIHSS]score of 3 or less at the time of randomization)
- All subjects will be clinically evaluated by a stroke neurologist
- All subjects will be evaluated with CT scan or MRI to exclude other causes of neurological symptoms different than brain ischemia
- Patients with independence: modified Rankin score<3
- Patients with a critical carotid stenosis will be included after revascularization therapy
- Written informed consent
Who cannot join
- Having serious comorbidities: dementia, advanced Cancer, excessive intake of alcohol (> 280 gr/week), severe renal or hepatic insufficiency and severe cardiac failure
- Currently receiving an investigational drug or device
- Age<18 years
- Patient or family declining to take part
- Pregnant or breastfeeding
- Transient neurological deficit for < 5 minutes
About this study
Official title: Integrated Care Improves Risk-factor Modification After Transient Ischemic Attack or Minor Stroke Patients (Lleida TIA Intervention Study)
Having a transient ischemic attack (TIA) or a minor stroke is a real risk factor not only for early recurrent stroke but also for major extracranial vascular events. Despite these warning events provide an opportunity for prevention usual post-discharge care of these subjects (mainly at primary care) is not associated with an optimal control of cerebrovascular risk factors (CRF). The investigators hypothesized that patients exposed to the intensified integrated multifactorial interventional care program (ICP) model would exhibit better management of CRF and receive more targeted advice than patients receiving standard care. A second objective was to investigate the effect of the ICP model on stroke recurrence or the appearance of major extracranial vascular events.
To test this hypothesis the investigators perform a controlled, randomized, single blind, parallel trial. Subjects are recruited at the Stroke Unit and are randomized into two groups: 1. usual care (control group) and 2. ICP (intervention group). Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo ICP. This ICP involves strict treatment goals (LDL-cholesterol <100 mg/dl, blood pressure <130/80 mmHg, HbA1c<7%, no smoking, regular exercise and no excessive alcohol consumption) to be achieved through behavior modification (diet, physical activity, smoking cessation, alcohol cessation) and a stepwise introduction of pharmacologic therapy for the main CRF (hypercholesterolemia, hypertension and diabetes). This multifactorial intervention is overseen in each primary care center by a trained general practitioner and nursery. The treatment goals are the same for the control group and the intervention group. General practitioners caring patients of each group are informed of these strict treatment goals. Patients in the ICP group receive a minimum of four scheduled individual consultations in one year (baseline, 3, 6 and 9 months). Primary and secondary outcomes are evaluated by an external Neurologist at 12 months after their inclusion.
- Conditions
- Transient Ischemic Attack
- Being tested
- intensive integrated intervention care program
- Keywords
- transient ischemic attack
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive integrated intervention care programOther
intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
| Study group | Role | What they receive |
|---|---|---|
| Intensive integrated intervention care program | Experimental | intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events Receives: Other: intensive integrated intervention care program |
| Non intensive integrated intervention care program | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled blood pressure
Rate of patients with controlled blood pressure values (Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) and controlled LDL-c (levels <100 mg/dl)
Measured: 12 months
Controlled LDL levels
Rate of patients with controlled LDL-c (levels <100 mg/dl)
Measured: 12 months
Secondary outcomes (6)
Stroke recurrence
Rate of patients with stroke recurrence
Measured: 12 months
Stroke recurrence
Rate of patients with stroke recurrence
Measured: 5 years
Stroke recurrence
Rate of patients with stroke recurrence
Measured: 10 years
Major vascular events
Rate of patients with stroke recurrence
Measured: 12 months
Major vascular events
Rate of patients with stroke recurrence
Measured: 5 years
Major vascular events
Rate of patients with stroke recurrence
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Mar 2011
- Primary completion1 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Ischemic AttackStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intensive integrated intervention care program \[ICP\] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recerca Biomèdica de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Purroy, Institut de Recerca Biomèdica de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524078
- Sponsor's protocol ID
- LLETIS 1.0
- Acronym
- LLETIS
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care Improves Risk-factor Modification After Transient Ischemic Attack or Minor Stroke Patients (Lleida TIA Intervention Study)
- ClinicalTrials.gov ID
- NCT04524078
- Acronym / sponsor ID
- LLETIS / LLETIS 1.0
- Conditions
- Transient Ischemic Attack
- Keywords
- transient ischemic attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut de Recerca Biomèdica de LleidaUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Aug 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.
Having a transient ischemic attack (TIA) or a minor stroke is a real risk factor not only for early recurrent stroke but also for major extracranial vascular events. Despite these warning events provide an opportunity for prevention usual post-discharge care of these subjects (mainly at primary care) is not associated with an optimal control of cerebrovascular risk factors (CRF). The investigators hypothesized that patients exposed to the intensified integrated multifactorial interventional care program (ICP) model would exhibit better management of CRF and receive more targeted advice than patients receiving standard care. A second objective was to investigate the effect of the ICP model on stroke recurrence or the appearance of major extracranial vascular events.
To test this hypothesis the investigators perform a controlled, randomized, single blind, parallel trial. Subjects are recruited at the Stroke Unit and are randomized into two groups: 1. usual care (control group) and 2. ICP (intervention group). Patients assigned to receive usual care (general practitioner with the possibility of being referred to specialists) are compared to those assigned to undergo ICP. This ICP involves strict treatment goals (LDL-cholesterol <100 mg/dl, blood pressure <130/80 mmHg, HbA1c<7%, no smoking, regular exercise and no excessive alcohol consumption) to be achieved through behavior modification (diet, physical activity, smoking cessation, alcohol cessation) and a stepwise introduction of pharmacologic therapy for the main CRF (hypercholesterolemia, hypertension and diabetes). This multifactorial intervention is overseen in each primary care center by a trained general practitioner and nursery. The treatment goals are the same for the control group and the intervention group. General practitioners caring patients of each group are informed of these strict treatment goals. Patients in the ICP group receive a minimum of four scheduled individual consultations in one year (baseline, 3, 6 and 9 months). Primary and secondary outcomes are evaluated by an external Neurologist at 12 months after their inclusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
| Arm | Type | Receives |
|---|---|---|
| Intensive integrated intervention care program | Experimental | Other: intensive integrated intervention care programintensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events |
| Non intensive integrated intervention care program | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with transient ischemic attack (reversible episode of neurological deficit of ischemic origin that resolved completely within 24 hours) or minor stroke (established neurological deficit of ischemic origin with US National Institutes of Health stroke scale [NIHSS]score of 3 or less at the time of randomization)
- All subjects will be clinically evaluated by a stroke neurologist
- All subjects will be evaluated with CT scan or MRI to exclude other causes of neurological symptoms different than brain ischemia
- Patients with independence: modified Rankin score<3
- Patients with a critical carotid stenosis will be included after revascularization therapy
Key exclusion criteria (6 listed)
- Having serious comorbidities: dementia, advanced Cancer, excessive intake of alcohol (> 280 gr/week), severe renal or hepatic insufficiency and severe cardiac failure
- Currently receiving an investigational drug or device
- Age<18 years
- Patient or family declining to take part
- Pregnant or breastfeeding
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 |
|---|---|---|
| intensive integrated intervention care programintensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events | Other | Intensive integrated intervention care program |
Primary outcome
Controlled blood pressure
Time frame: 12 months
Rate of patients with controlled blood pressure values (Systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg) and controlled LDL-c (levels <100 mg/dl)
Controlled LDL levels
Time frame: 12 months
Rate of patients with controlled LDL-c (levels <100 mg/dl)
6 secondary outcomes
Stroke recurrence
Time frame: 12 months
Stroke recurrence
Time frame: 5 years
Stroke recurrence
Time frame: 10 years
Major vascular events
Time frame: 12 months
Major vascular events
Time frame: 5 years
Major vascular events
Time frame: 10 years
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 24 Aug 2020.
Related trials for Transient Ischemic Attack
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
Recruiting
Neuromodulation-Enhanced Use of RObotic BALANCE Training to Improve Balance Function in Individuals With Stroke
Stroke, Stroke (CVA) or Transient Ischemic Attack
RecruitingObservational study
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI)
Ulcerative Colitis, Myocardial Infarction
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?
A study testing intensive integrated intervention care program in people with Transient Ischemic Attack, run by Institut de Recerca Biomèdica de Lleida.
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 6 inclusion and 6 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 24 Aug 2020. 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?
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?
Controlled blood pressure (time frame: 12 months). 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 24 Aug 2020.