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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT06315192
Eligibility Criteria:
INCLUSION CRITERIA
1. Age 50 years or older
2. Modified Rankin scale of 0-2.
3. Diagnosed with either:
A. Recent\* transient ischemic attack (TIA, G45.9), AND:
* ABCD2 score of ≥6, OR:
* Atrial fibrillation OR:
* Large artery atherosclerosis\*\*.
B. Recent\* acute ischemic stroke (I63), AND:
• Atrial fibrillation, OR:
* Large artery atherosclerosis\*\*. C. Atrial fibrillation/flutter (I48), AND
* None, or reduced dose of, oral anticoagulation medication\*\*\*, AND
* CHA2DS2-VASC score ≥4.
D. Recent\* intracerebral hemorrhage (I61.9), AND:
• Atrial fibrillation.
4. The patient has received the required information about the study and agrees in writing to participate.
5. Smartphone user since at least 1 year.
* Within the last 2 weeks \*\*Atherosclerosis in carotid, vertebral aortic arch or major intracerebral arteries according to CTA or ultrasound.
* Including all oral anticoagulation medication such as Warfarin and NOACs. Patients with reduced dose of a NOAC can be included, regardless if this is within the approved label, or if reduced dose is chosen off-label for other reasons. Treatment with antiplatelet medication is permissible.
EXCLUSION CRITERIA
1. Previous inclusion in this study.
2. Arm motor deficit from any previous medical condition.
3. Unable to give informed consent to participate in the study.
4. Does not master any of the languages available within the Stroke Alarm smartphone app in speech and writing.
5. Does not have access to a Stroke Alarm compatible smartphone.
6. Deemed unable to handle the Stroke Alarm smartphone app, or participate in planned follow-up within the framework of the study due to other diseases or circumstances.
7. Does not want to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06315192
Study Brief:
Protocol Section:
NCT06315192