Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05494034 |
| Other study ID # |
ICM07082022 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2023 |
| Est. completion date |
January 1, 2030 |
Study information
| Verified date |
November 2023 |
| Source |
National and Kapodistrian University of Athens |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In this prospective cohort study, the investigators aim to investigate the incidence of
ICM-detected AF in unselected ischemic stroke patients and its association with
anticoagulation initiation and stroke recurrence.
Description:
The study will be conducted among 4 tertiary centers of the cardioneurology network in the
Athens Metropolitan area ("Attikon" University Hospital, Hippokrateion Hospital, "Georgios
Gennimatas" General Hospital of Athens, NIMITS General Hospital of Athens). The Second
Department of Neurology of the National and Kapodistrian University of Athens in "Attikon"
University Hospital would also act as the coordinating center, comprising of a research group
with significant clinical experience and numerous publications on PCM and stroke.
Consecutive acute ischemic stroke or TIA patients aged 40 years or older will be enrolled.
Diagnosis of acute ischemic stroke will be based on clinical and neuroimaging evaluation
[brain computed tomography (CT) scan or magnetic resonance imaging (MRI) scan].
Classification of stroke will be defined using the Trial of Org 10172 in Acute Stroke
Treatment (TOAST) criteria. Patients with incomplete evaluation will be excluded, as
previously described. Patients with known or newly detected AF at hospitalization will also
be excluded. Stroke patients of all other etiologies presenting a HAVOC score ≥4 will be
included in the study. Informed consent for participation in the study will be obtained from
the patients or guardians of patients.
Sample size
Similar to previous studies, approximately 200 eligible patients will be recruited during a
4-year period (50 patients/year). Based on a retrospective analysis of the local stroke
registry and considering the eligibility criteria for this study, it is estimated that at
least 1,000 stroke patients should be screened in order to enroll 200 participants.
Baseline Evaluation
All demographics and vascular risk factors will be prospectively recorded for all patients
using standard definitions. Complete hematological and biochemical screening, as well as
immunological and thrombophilia testing where indicated, will be performed. A comprehensive
stroke etiopathogenic evaluation will be performed, including neuroimaging with brain
computed tomography (CT) and / or magnetic resonance imaging (MRI), vascular imaging
(cervical duplex ultrasound, transcranial Doppler, CT angiography and / or magnetic resonance
[MR] angiography), ECG, transthoracic and/or transesophageal echocardiography and
24-to-48-hour Holter-ECG monitoring.
In particular, among the risk factors assessed, the age at inclusion, the number of atrial
premature beats during the Holter-ECG monitoring, the location of index ischemic stroke
(cortical versus deep), the brain natriuretic peptide (BNP) values, the presence of left
atrial enlargement as diagnosed according to the guidelines of the American Society of
Echocardiography, the HAVOC score (hypertension, age, valvular heart disease, peripheral
vascular disease, obesity, congestive heart failure, coronary artery disease), the
CHA₂DS₂-VASc score and the HAS-BLED score will be also recorded.
Stroke severity on admission will be assessed with the use of the National Institute of
Health Stroke Scale (NIHSS) score by certified neurologists. Stroke classification according
to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) will be performed by certified
neurologists, comprising of five stroke subtypes: (a) large-artery atherosclerosis; (b)
cardioembolism; (c) small-vessel occlusion; (d) stroke of other determined etiology; and (e)
stroke of undetermined etiology.[23] Interventions All included patients will receive
secondary stroke prevention treatment and long-term management depending on the stroke
subtype and according to current guidelines.
All included patients will have long-term heart rate monitors (Reveal LINQ; Medtronic)
implanted subcutaneously under local anesthesia in the left chest region. During monitoring
time, all patients with ICM will be evaluated clinically and electrocardiographically for up
to 3 years following hospital discharge. Follow-up visits will be performed at the stroke
outpatient clinic of our institution by outpatient visits and / or telephone, as dictated by
their clinical status and at the discretion of the treating vascular neurologist, as
previously described. All ICM recordings will be reviewed by a specialized cardiologist. All
included patients will also be monitored with annual MRI scans for up to 3 years.
In the cases of AF detection, anticoagulant treatment may be initiated at the discretion of
the treating physician, considering that the CHA₂DS₂-VASc score of the included patients will
be at least 2 points, due to the history of stroke.
Statistical Analysis
Continuous variables will be presented as mean ± SD (normal distribution) and as median with
interquartile range (IQR, skewed distribution). Categorical variables will be presented as
number of patients and the corresponding percentages. Statistical comparisons between two
groups (AF detected and no-AF detected) will be performed using χ2 test, or in case of small
expected frequencies, Fisher's exact test. Continuous variables will be compared by the use
of the unpaired t test or Mann-Whitney U test, as indicated. Cumulative probabilities of AF
by risk factors will be displayed according to the Kaplan-Meier method. Event rates will be
compared using the log-rank statistic. Univariable and multivariable Cox proportional hazards
regression models will be used to determine predictors of AF. Baseline variables having
differences with a significance level <0.10 will be considered as candidates for
multivariable time-to-event AF models. Statistical significance will be achieved if the p
value is ⩽0.05 in multivariable logistic regression analyses. The Statistical Package for
Social Science (SPSS Inc, Armonk, NY, USA; version 23.0 for Windows) will be used for
statistical analyses.
