Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542770
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke A Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
CRIPTO-FAST
Brief Summary:
Cryptogenic stroke CS causes about 30 of admissions to a stroke unit Silent paroxysmal atrial fibrillation PAF is believed to be the underlying cause of a significant proportion of patients The use of implantable cardiac monitors ICM early after the CS has demonstrated benefits in the diagnostic yield but the indication for ICM in the current guidelines remains unclear Atrial contraction strain ACS evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF
The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS Clinical and ultrasound predictors of PAF occurrence ACS will be studied in order to define patients needing a closer follow-up
The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS Clinical and ultrasound predictors of PAF occurrence ACS will be studied in order to define patients needing a closer follow-up
Detailed Description:
Introduction
Cryptogenic stroke CS is a stroke in which etiology cannot be determined after a comprehensive evaluation and it is the cause of about 30 of admissions to a stroke unit In these cases single antiplatelet therapy is recommended as a long term treatment However silent paroxysmal atrial fibrillation PAF is believed to be the underlying cause of a significant proportion of episodes and its recognition merits urgency since carries to oral anticoagulation OAC and antiplatelet therapy cessation According to guidelines in order to detect PAF we need to monitor the patients ECG for at least 48h although the longer the monitoring is the better the diagnostic yield
Previous research showed controversial results regarding the use of implantable cardiac monitors ICM in such patients when the ICM had been implanted late after the CS On the other hand studies with an early implant demonstrated a clear benefit in the diagnostic yield To date the strategy to search actively for PAF in patients with CS is still not well established and even when internal loop recorders ILR are our best option to recognize paroxysmal arrhythmic events guidelines are not clear about the cases in which they might be indicated Some markers such as age cardiovascular risk factors blood biomarkers or cardiac ultrasound characteristics have been related to a higher silent PAF detection Recent data points at the use of left atrium atrial strain LAS to select the patients more prone to suffer from silent PAF
It remains to be defined the usefulness of ILR implanted early after the CS in order to diagnose the presence of silent PAF and the roll or ACS in such patients in order to predict those being at higher risk
Methods
This is a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS During the first 48 hours from admission patients were randomized to receive standard care Control Group or early ICM implantation Study Group before discharge A special effort will be made to search for the clinical and ultrasound atrial predictors of PAF occurrence in order to better define what patients need a closer follow-up
Ultrasound evaluation
The following ultrasound atrial features will be studied to separate patients into two categories
1 LA dilatation indexed volumen 32 mlm2
2 PALS Peak atrial longitudinal strain 21
3 PACS Peak atrial contraction strain 13
4 Atrial ejection fraction 55
Patients will be considered as having a normal LA if none of the above mentioned characteristics is accomplished in opposition to patients who accomplish at least one characteristic described above which will be considered as atrial cardiomyopathy patients
Patients will be immediately treated with antiplatelet treatment OAC will be started if PAF is detected during admission Whilst in the Stroke Unit all patients will be continuously ECG-monitored for at least 48 h and will undergo a cardiac transthoracic echocardiogram with complete evaluation of strain parameters
Demographic factors vascular risk factors and comorbidities will be collected Work-up during admission will include at least a complete neurological examination 12-lead ECG brain computed tomography CT blood test and neurovascular imaging magnetic resonance angiography angioCT andor two-dimensional ultrasound of supra-aortic trunks and intracranial territory
The diagnosis of CS will be revisited in all patients 3 months after the index episode and those found to have any potential cause other than PAF will be additionally excluded The study follows national and international principles Declaration of Helsinki and it was approved by the local ethics committee All patients are required to sign the specific informed consent
Strategies for PAF detection Since the prevalence of AF is higher in patients having LA anomalies we will divide the total group into two categories before randomization depending on the presence or absence of LA dilatation andor impaired ACS Then we will randomize all patients to Control Group or Study Group
Control group after discharge from the Stroke Unit patients in the control group will be studied with daily ECGs whilst admitted at the hospital Outpatient serial ECGs will be performed at the time of each visit at the Neurology Clinic 3 6 and 12 months after the stroke and every 6 months thereafter Additional ECGs will be performed if patients had symptoms potentially related to PAF Furthermore all patients will undergo a 72h-Holter-monitoring scheduled 1 month after discharge
Study group patients in the active study group will undergo an ICM implant 3-4 days after the stroke and prior to discharge All devices Abbott Jot will be implanted subcutaneously under local anaesthesia in the left chest region and programmed with an specific algorithm for AF detection set at 30 seconds for detection All patients will be included in remote monitoring system Merlin which will be programmed to send alerts in case of registering episodes qualifying for AF detection and a monthly routine registration All ICM recordings will be reviewed by a specialized cardiologist Patients will be seen at the arrhythmia and the neurology outpatient clinics at 3 6 and 12 months after the stroke and every 6 months thereafter
End-points and follow-up Primary clinical outcome detection of AF at follow-up which is defined by the presence of a confirmatory 12-leads ECG or a registration lasting more than 30 seconds in either the 72h-Holter-Monitoring or in the ICM recording In case of AF detection OAC will be initiated immediately
Secondary clinical outcomes ultrasounds predictors for AF occurrence LA indexed volumen maximum systolic global longitudinal strain PALs atrial contraction strain PACs atrial ejection fraction
We also will search for stroke recurrences defined as new neurological events recorded after hospital discharge and validated by a vascular neurologist
Statistical analysis Results are reported as mean SD median p25-p75 or frequency Comparisons between groups were performed with the Student t test or chi-squared analysis The association between clinical variables and the study end-points was evaluated using survival analysis methodology Cox regression models The Kaplan-Meier method was used to estimate the cumulative probability of PAF detection and stroke recurrence in both groups and comparisons were made by the log-rank test Significance was set at P 005
Cryptogenic stroke CS is a stroke in which etiology cannot be determined after a comprehensive evaluation and it is the cause of about 30 of admissions to a stroke unit In these cases single antiplatelet therapy is recommended as a long term treatment However silent paroxysmal atrial fibrillation PAF is believed to be the underlying cause of a significant proportion of episodes and its recognition merits urgency since carries to oral anticoagulation OAC and antiplatelet therapy cessation According to guidelines in order to detect PAF we need to monitor the patients ECG for at least 48h although the longer the monitoring is the better the diagnostic yield
Previous research showed controversial results regarding the use of implantable cardiac monitors ICM in such patients when the ICM had been implanted late after the CS On the other hand studies with an early implant demonstrated a clear benefit in the diagnostic yield To date the strategy to search actively for PAF in patients with CS is still not well established and even when internal loop recorders ILR are our best option to recognize paroxysmal arrhythmic events guidelines are not clear about the cases in which they might be indicated Some markers such as age cardiovascular risk factors blood biomarkers or cardiac ultrasound characteristics have been related to a higher silent PAF detection Recent data points at the use of left atrium atrial strain LAS to select the patients more prone to suffer from silent PAF
It remains to be defined the usefulness of ILR implanted early after the CS in order to diagnose the presence of silent PAF and the roll or ACS in such patients in order to predict those being at higher risk
Methods
This is a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS During the first 48 hours from admission patients were randomized to receive standard care Control Group or early ICM implantation Study Group before discharge A special effort will be made to search for the clinical and ultrasound atrial predictors of PAF occurrence in order to better define what patients need a closer follow-up
Ultrasound evaluation
The following ultrasound atrial features will be studied to separate patients into two categories
1 LA dilatation indexed volumen 32 mlm2
2 PALS Peak atrial longitudinal strain 21
3 PACS Peak atrial contraction strain 13
4 Atrial ejection fraction 55
Patients will be considered as having a normal LA if none of the above mentioned characteristics is accomplished in opposition to patients who accomplish at least one characteristic described above which will be considered as atrial cardiomyopathy patients
Patients will be immediately treated with antiplatelet treatment OAC will be started if PAF is detected during admission Whilst in the Stroke Unit all patients will be continuously ECG-monitored for at least 48 h and will undergo a cardiac transthoracic echocardiogram with complete evaluation of strain parameters
Demographic factors vascular risk factors and comorbidities will be collected Work-up during admission will include at least a complete neurological examination 12-lead ECG brain computed tomography CT blood test and neurovascular imaging magnetic resonance angiography angioCT andor two-dimensional ultrasound of supra-aortic trunks and intracranial territory
The diagnosis of CS will be revisited in all patients 3 months after the index episode and those found to have any potential cause other than PAF will be additionally excluded The study follows national and international principles Declaration of Helsinki and it was approved by the local ethics committee All patients are required to sign the specific informed consent
Strategies for PAF detection Since the prevalence of AF is higher in patients having LA anomalies we will divide the total group into two categories before randomization depending on the presence or absence of LA dilatation andor impaired ACS Then we will randomize all patients to Control Group or Study Group
Control group after discharge from the Stroke Unit patients in the control group will be studied with daily ECGs whilst admitted at the hospital Outpatient serial ECGs will be performed at the time of each visit at the Neurology Clinic 3 6 and 12 months after the stroke and every 6 months thereafter Additional ECGs will be performed if patients had symptoms potentially related to PAF Furthermore all patients will undergo a 72h-Holter-monitoring scheduled 1 month after discharge
Study group patients in the active study group will undergo an ICM implant 3-4 days after the stroke and prior to discharge All devices Abbott Jot will be implanted subcutaneously under local anaesthesia in the left chest region and programmed with an specific algorithm for AF detection set at 30 seconds for detection All patients will be included in remote monitoring system Merlin which will be programmed to send alerts in case of registering episodes qualifying for AF detection and a monthly routine registration All ICM recordings will be reviewed by a specialized cardiologist Patients will be seen at the arrhythmia and the neurology outpatient clinics at 3 6 and 12 months after the stroke and every 6 months thereafter
End-points and follow-up Primary clinical outcome detection of AF at follow-up which is defined by the presence of a confirmatory 12-leads ECG or a registration lasting more than 30 seconds in either the 72h-Holter-Monitoring or in the ICM recording In case of AF detection OAC will be initiated immediately
Secondary clinical outcomes ultrasounds predictors for AF occurrence LA indexed volumen maximum systolic global longitudinal strain PALs atrial contraction strain PACs atrial ejection fraction
We also will search for stroke recurrences defined as new neurological events recorded after hospital discharge and validated by a vascular neurologist
Statistical analysis Results are reported as mean SD median p25-p75 or frequency Comparisons between groups were performed with the Student t test or chi-squared analysis The association between clinical variables and the study end-points was evaluated using survival analysis methodology Cox regression models The Kaplan-Meier method was used to estimate the cumulative probability of PAF detection and stroke recurrence in both groups and comparisons were made by the log-rank test Significance was set at P 005
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