Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Current intervention as of 29/12/2021:
The DiVERT Stroke Phase I Clinical Study is a retrospective data collection study investigating hospital admissions of cryptogenic stroke, large artery atheroscl
Sponsors
Medtronic (United States)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 29/12/2021: The following data will be collected for all subjects within 12 months prior to the index stroke hospitalization through medical records review: 1. Medical history 2. Alcohol consumption 3. CHA2DS2 VASc Score (most recent within 12 months prior to index hospitalization) 4. Lab tests: CRP, BNP (most recent within 12 months prior to index hospitalization) The following data will be collected for all subjects at index stroke hospitalization through medical records review: 1. Hospitalization dates (e.g., admission, discharge) 2. Neurology diagnostic testing 3. EP consultation 4. Short-term/external monitors, wearables, and/or ICM recommendation (if applicable) 5. Short-term/external monitors, wearables, and/or ICM use (if applicable) The following data will be collected for all subjects at follow-up visits through 180 days post-index stroke hospitalization (i.e. discharge) through medical records review: 1. Discharge location (SNF, inpatient, home, etc.) 2. Prescribed stroke-related follow-up cadence (office and remote) 3. Stroke-related follow-up dates 4. Neurology diagnostic testing The following economic data evaluated through medical records and hospital cost/charge accounting data for all subjects at 30-, 60-, 90-, 180-days post-hospital discharge: 1. Total cost of stroke diagnostic work-up for index hospitalization and through 180 days follow-up 2. Total cost of index stroke hospitalization 3. Total cost short-term/external monitoring 4. Total cost pre- and post-ICM insertion 5. Total cost of care 30, 60, 90, 180 days post-stroke, including cardiovascular disease and atrial fibrillation (AF) healthcare utilization costs 6. Total cost of stroke readmissions and stroke recurrences, including healthcare utilization _____ Previous primary outcome measures: The following information will be collected through medical records and hospital cost/charge accounting data within 12 months prior to the index stroke hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/12/2021: The previous secondary outcome measures are now primary outcome measures, therefore there are currently no secondary outcome measures. _____ Previous secondary outcome measures: Evaluated through medical records and hospital cost/charge accounting data at 30-, 60-, 90-, 180-days post-hospital discharge: 1. Total cost of stroke diagnostic work-up for index hospitalization and through 180 days follow-up 2. Total cost of index stroke hospitalization 3. Total cost short-term/external monitoring 4. Total cost pre- and post-ICM insertion 5. Total cost of care 30, 60, 90, 180 days post-stroke, including cardiovascular disease and atrial fibrillation (AF) healthcare utilization costs 6. Total cost of stroke readmissions and stroke recurrences, including healthcare utilization | — |
Countries
England, United Kingdom, United States of America
Contacts
Public ContactJessica Mikacevich
Outcome results
None listed