Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548269
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Multimodal Prognostic Assessment of AIS With AF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal Prognostic Assessment of Acute Ischemic Stroke Patients With Atrial Fibrillation a Prospective Multicenter Observational Study IAT-CLOSURE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to investigate the safety and outcomes of different treatment strategies including best medical therapy OAC oral anticoagulation antiplatelet APT and left atrial appendage closure LAAC in acute ischemic stroke AIS patients with atrial fibrillation AF based on multimodal assessment from combined brain and cardiologic work-up and to optimize secondary prevention
Detailed Description:
Ischemic stroke is the leading cause of disability and mortality globally Atrial fibrillationAF is a well-established risk factor for ischemic stroke and responsible for up to one-third of all strokes AF-related ischemic strokes are more frequently fatal or disabling than non-AF strokes The overall prevalence of known or newly diagnosed AF in stroke patients is approximately 390 Detecting underlying AF remains important for secondary prevention of recurrent stroke with a different strategy from atherosclerotic cause of stroke The increasingly common use of prolonged cardiac monitoring PCM after ischemic stroke has greatly increased the detection rates of previously undiagnosed AF in ischemic strokes which was demonstrated by a series of trials Additionally AF burden defined as percentage of the time in AF during cardiac monitoring has been regarded as an important prognostic risk factor for thromboembolism
Currently the CHA2DS2-VASc score is the most widely used scoring system for assessing ischemic stroke risk in patients with AF and basis for initiation of anticoagulation Anticoagulation is currently recommended for male with CHA2DS2-VASc score2 or female with CHA2DS2-VASc score3 Direct oral anticoagulants DOACs have been increasingly used in the past decade due to their similar to superior efficacy to vitamin K antagonists VKAs but a lower intracerebral bleeding risk in non-valvular atrial fibrillation NVAF defined as AF in the absence of moderate to severe mitral stenosis or a mechanical heart valve For patients with AF who cannot tolerate long-term OACs due to various relative or absolute contraindications left atrial appendage closure LAAC offers an alternative treatment strategy for these patients Moreover as one-third of patients with ischemic stroke and AF may have concomitant large artery atherosclerosis or small vessel disease it is still unclear whether these patients should be left untreated or treated with antiplatelet APT DOACs or with LAAC
Traditional clinical practice mainly focuses on the presence of AF but rarely incorporates AF burden into a risk stratification scoring system To our knowledge no studies to date have investigated recurrent stroke risk stratification in AIS patients with AF based on AF burden assessed by PCM not to mention guidance of treatment strategy selection Further other multimodal assessments such as cerebral CTMRI eg infarct size and location serum biomarkers eg BNP troponin D-dimer levels and cardiac structural markers eg LA volume or volume index LAA morphologies have been reported as promising prognostic factors of stroke severity and recurrence A comprehensive evaluation system is still lacking In this prospective and multicenter registry study we determine to test the safety and effectiveness of best medical therapy OAC APT and LAAC using multimodal assessment from combined brain and cardiologic work-up with the aim to optimize secondary prevention in this patient population
Currently the CHA2DS2-VASc score is the most widely used scoring system for assessing ischemic stroke risk in patients with AF and basis for initiation of anticoagulation Anticoagulation is currently recommended for male with CHA2DS2-VASc score2 or female with CHA2DS2-VASc score3 Direct oral anticoagulants DOACs have been increasingly used in the past decade due to their similar to superior efficacy to vitamin K antagonists VKAs but a lower intracerebral bleeding risk in non-valvular atrial fibrillation NVAF defined as AF in the absence of moderate to severe mitral stenosis or a mechanical heart valve For patients with AF who cannot tolerate long-term OACs due to various relative or absolute contraindications left atrial appendage closure LAAC offers an alternative treatment strategy for these patients Moreover as one-third of patients with ischemic stroke and AF may have concomitant large artery atherosclerosis or small vessel disease it is still unclear whether these patients should be left untreated or treated with antiplatelet APT DOACs or with LAAC
Traditional clinical practice mainly focuses on the presence of AF but rarely incorporates AF burden into a risk stratification scoring system To our knowledge no studies to date have investigated recurrent stroke risk stratification in AIS patients with AF based on AF burden assessed by PCM not to mention guidance of treatment strategy selection Further other multimodal assessments such as cerebral CTMRI eg infarct size and location serum biomarkers eg BNP troponin D-dimer levels and cardiac structural markers eg LA volume or volume index LAA morphologies have been reported as promising prognostic factors of stroke severity and recurrence A comprehensive evaluation system is still lacking In this prospective and multicenter registry study we determine to test the safety and effectiveness of best medical therapy OAC APT and LAAC using multimodal assessment from combined brain and cardiologic work-up with the aim to optimize secondary prevention in this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None