Secondary stroke prevention through pathway management

Not Applicable

Completed

• Conditions: Stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN87407792
• Lead Sponsor: Medtronic (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study Completion: 2024-03-19
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6536

Inclusion Criteria

Current inclusion criteria as of 01/09/2022:
US Inclusion Criteria:
1. Patients with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion hospitalization between 2017 – 2019
2. Age =18 years

UK Inclusion Criteria:
1. Patients with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion hospitalization between 2019-2020. If ischemic stroke sub-type classification proves to be difficult (i.e., small sample size), patients with an ischemic stroke from 2017-2019 will be included.
2. Age =18 years

Previous inclusion criteria from 20/05/2021 to 01/09/2022:
1. Patients with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion
hospitalization between 2017 – 2019
2. Age =18 years

Previous inclusion criteria:
1. Patients with a cryptogenic stroke hospitalization defined by ICD-10 I63.9 between 2017 – 2019
2. Age =18 years

Exclusion Criteria

Current exclusion criteria as of 20/05/2021:
Does not meet inclusion criteria

Previous exclusion criteria:
1. Any history of the following through index stroke:
1.1. Lacunar stroke
1.2. Large artery atherosclerosis
1.3. Diagnosis of AF or atrial flutter
1.4. Ablation for AF or atrial flutter
1.5. OAC use
1.6. Methamphetamines drug use
1.7. Mechanical heart valves
1.8. Rheumatic heart disease
1.9. Mitral stenosis
1.10. Ischemic cardiomyopathy
1.11. Dilated cardiomyopathy
1.12. ST-elevation MI
1.13. Vasculitis
1.14. End stage renal disease
1.15. ICM implant prior to index event
2. VT Ablation within 30 days of index event
3. Non-AF left atrial or ventricular ablation within 30 days of index event
4. Any of the following within 30 days pre to 90 days post index stroke:
4.1. Carotid artery stenting
4.2. Carotid endarterectomy
4.3. Carotid artery stenosis or occlusion
4.4. ASD closure device insertion

Study & Design

• Study Type: Observational
• Study Design: Not specified