Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT06486792
Eligibility Criteria:
Inclusion Criteria:
Included patients must fulfill the following 4 criteria:
1. patient aged ≥65 years with:
1. recent (\<15 days) cerebral infarction
2. with cerebral ischemia proven on MRI or head-CT
2. with no known atrial fibrillation before stroke and no atrial fibrillation detected during hospital stay (monitoring or telemetry) and no mural thrombus.
3. but with suspected atrial fibrillation:
1. multiple territorial (i.e., in the territory of a cerebral artery or one of its branches) cerebral infarctions in several arterial territories involving both hemispheres, or in the same hemisphere, or in both anterior and posterior circulation, symptomatic or not
2. or a single cerebral infarction and systemic emboli (e.g., renal, splenic, hepatic or mesenteric infarction, peripheral emboli in arm or leg), symptomatic or not
3. or any ischemic stroke with dilation of atrium (\>34 mL/m²) or left atrial spontaneous echocardiographic contrast or LAA velocities \< 40 cm/sec or pro BNP \> 400 pg/mL or left ventricular ejection fraction (LVEF) \< 40% or supraventricular extrasystole ≥ 400/24 h or longest "atrial run" ≥ 20 beats on telemetry
4. or age ≥80 year-old and a single infarction
4. and a plan to detect atrial fibrillation with, long term Holter ECG, wearing device or implantable loop recorder
5. with a Rankin score equal or less than 4
6. patient has signed an informed consent
7. Patient is affiliated to a social security.
Exclusion Criteria:
1. Patients with a known cause of stroke, using ASCOD classification A1, C1, S1, O1, D1
2. Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria)
3. Uncontrolled hypertension (following the judgment of the investigator)
4. Clear indication to anticoagulant or antiplatelet therapy
5. Contra-indication to anticoagulant or antiplatelet therapy
6. Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits
7. Participation in another interventional clinical trial.
8. Under contraception in case of childbearing potential
9. Patient under guardianship or curatorship
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06486792
Study Brief:
Protocol Section:
NCT06486792