Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582825
Status:
RECRUITING
Last Update Posted:
2023-08-09
First Post:
2020-10-03
Brief Title:
Stroke-Card Registry
Sponsor:
VASCage GmbH
Organization:
VASCage GmbH
Study Overview
Official Title:
STROKE-CARD REGISTRY Extension of Standard Care in Patients With Ischemic Stroke and Transient Ischemic Attack
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is the second leading cause of death and one of the main contributors to disability Patients who survive the acute phase of ischemic stroke and those with transient ischemic attack TIA are at high risk of subsequent vascular events Importantly recurrent strokes are associated with a higher social and economic impact higher case fatality and worse clinical outcome than first-ever strokes The burden of post-stroke complications residual deficits and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial NCT02156778 between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care After implementation of STROKE-CARD care the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time Furthermore the investigators aim to gain a large data-resource for future research of biomarkers disease mechanisms prognosis and imaging mechanisms for RD
Detailed Description:
Stroke is the second leading cause of death and one of the main contributors to disability Patients who survive the acute phase of ischemic stroke and those with a transient ischemic attack TIA are at high risk of subsequent stroke Importantly recurrent strokes are associated with a higher social and economic impact higher case fatality and worse clinical outcome than first-ever strokes The burden of post-stroke complications residual deficits and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients Furthermore effects on quality of life and long-term functional independence are particularly under-investigated
The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial NCT02156778 between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease management program STROKE-CARD care The aim is to evaluate this program in a large multicenter cohort and to establish a biobank of stroke and TIA-patients for future research and development projects
In brief the pragmatic and easily implementable STROKE-CARD care program reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischemic stroke or TIA in a timeframe of 12 months after the index event To investigate the effects of STROKE-CARD care on a large basis and over a longer period an evaluation of approximately 5000 patients is warranted
Whereas disease management programs typically rely on expert opinion the STROKE-CARD initiative moved from a purely empirical approach to a highly structured individualized and evidence-based procedure with professional outcome analysis The STROKE-CARD concept will be implemented in clinical practice and can serve as a model for other disease management initiatives
Acute and short-term management of stroke and TIA has improved tremendously over the past years with substantial advances in acute therapy implementation of comprehensive pathways for stroke and TIA and approval of novel highly effective preventive treatments As a main unmet challenge in stroke medicine strategies of long-term care have to be developed and rigorously tested in order to maintain improved short-term patient outcome in the long run
STROKE-CARD care reduced the one-year cumulative absolute risk of CVD and ameliorated the patients health-related quality of life at 12 months EQ-5D-3L overall utility score P0001 These findings were consistent in subgroups according to age sex and index event and were robust in the per-protocol analysis Among pre-specified secondary outcomes assessed at 12 months the investigators observed improvements in all individual dimensions of the EQ-5D-3L and in one-year functional outcome that each met the multiplicity-adjusted threshold for statistical significance Only a few previous trials of disease management programs in stroke and TIA patients have focused on recurrent CVD or quality of life as primary or secondary endpoints and none has considered long-term functional outcome after one year The previous trial was limited to a 12-month follow-up in selected individuals and the sustainability of benefits of STROKE-CARD care in a large nationwide cohort over a longer follow-up period remains to be determined
This study aims to detect post-stroke complications to estimate the patients demand for nursing services and support guideline-compliant secondary prevention with full achievement of target levels lifestyle modifications and in-person outcome assessment at 3 and 12 months after the index-event assessment of functional status impairment activity disability and participation handicap and health-related quality of life Additionally yearly follow-up telephone interviews for cardiovascular outcome and health parameters will be conducted In case of clinically indicated in-person follow-ups the interviews will be done in person during the clinical visits After the implementation of STROKE-CARD care the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time Furthermore the investigators aim to gain a large data resource for future research of biomarkers disease mechanisms prognosis and imaging mechanisms for RD
The main objective is to evaluate the Post-Stroke Disease Management program STROKE-CARD in a large multicenter cohort of stroke and TIA-patients and to establish a large clinical well-defined cohort Furthermore the investigators aim to gain a large data resource for future research of biomarkers disease mechanisms prognosis and imaging mechanisms for RD
To document and monitor the quality of the Post-Stroke Disease Management program in different centers and compare outcomes to the historical cohort as well as other published data Furthermore the investigators aim to constantly improve post-stroke care This registry can facilitate to monitor and document the effect on the primary and secondary outcomes
There will be no formal safety endpoints in this study No experimental procedures will be applied to patients and most of the procedures done are within the clinical routine Potential side effects of optimal secondary stroke prevention are recorded
The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial NCT02156778 between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease management program STROKE-CARD care The aim is to evaluate this program in a large multicenter cohort and to establish a biobank of stroke and TIA-patients for future research and development projects
In brief the pragmatic and easily implementable STROKE-CARD care program reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischemic stroke or TIA in a timeframe of 12 months after the index event To investigate the effects of STROKE-CARD care on a large basis and over a longer period an evaluation of approximately 5000 patients is warranted
Whereas disease management programs typically rely on expert opinion the STROKE-CARD initiative moved from a purely empirical approach to a highly structured individualized and evidence-based procedure with professional outcome analysis The STROKE-CARD concept will be implemented in clinical practice and can serve as a model for other disease management initiatives
Acute and short-term management of stroke and TIA has improved tremendously over the past years with substantial advances in acute therapy implementation of comprehensive pathways for stroke and TIA and approval of novel highly effective preventive treatments As a main unmet challenge in stroke medicine strategies of long-term care have to be developed and rigorously tested in order to maintain improved short-term patient outcome in the long run
STROKE-CARD care reduced the one-year cumulative absolute risk of CVD and ameliorated the patients health-related quality of life at 12 months EQ-5D-3L overall utility score P0001 These findings were consistent in subgroups according to age sex and index event and were robust in the per-protocol analysis Among pre-specified secondary outcomes assessed at 12 months the investigators observed improvements in all individual dimensions of the EQ-5D-3L and in one-year functional outcome that each met the multiplicity-adjusted threshold for statistical significance Only a few previous trials of disease management programs in stroke and TIA patients have focused on recurrent CVD or quality of life as primary or secondary endpoints and none has considered long-term functional outcome after one year The previous trial was limited to a 12-month follow-up in selected individuals and the sustainability of benefits of STROKE-CARD care in a large nationwide cohort over a longer follow-up period remains to be determined
This study aims to detect post-stroke complications to estimate the patients demand for nursing services and support guideline-compliant secondary prevention with full achievement of target levels lifestyle modifications and in-person outcome assessment at 3 and 12 months after the index-event assessment of functional status impairment activity disability and participation handicap and health-related quality of life Additionally yearly follow-up telephone interviews for cardiovascular outcome and health parameters will be conducted In case of clinically indicated in-person follow-ups the interviews will be done in person during the clinical visits After the implementation of STROKE-CARD care the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time Furthermore the investigators aim to gain a large data resource for future research of biomarkers disease mechanisms prognosis and imaging mechanisms for RD
The main objective is to evaluate the Post-Stroke Disease Management program STROKE-CARD in a large multicenter cohort of stroke and TIA-patients and to establish a large clinical well-defined cohort Furthermore the investigators aim to gain a large data resource for future research of biomarkers disease mechanisms prognosis and imaging mechanisms for RD
To document and monitor the quality of the Post-Stroke Disease Management program in different centers and compare outcomes to the historical cohort as well as other published data Furthermore the investigators aim to constantly improve post-stroke care This registry can facilitate to monitor and document the effect on the primary and secondary outcomes
There will be no formal safety endpoints in this study No experimental procedures will be applied to patients and most of the procedures done are within the clinical routine Potential side effects of optimal secondary stroke prevention are recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None