Secondary stroke prevention through pathway management
| ISRCTN | ISRCTN87407792 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87407792 |
| IRAS number | 316927 |
| Secondary identifying numbers | MDT20034, IRAS 316927 |
- Submission date
- 08/03/2021
- Registration date
- 15/03/2021
- Last edited
- 17/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Every year, more than 795,000 people in the United States have a stroke. Stroke-related costs in the United States came to nearly $46 billion between 2014 and 2015. This total includes the cost of health care services, medicines to treat stroke, and missed days of work. Stroke is a leading cause of serious long-term disability and reduces mobility in more than half of stroke survivors aged 65 and over. In February 2020, the Global Research Report looked at ICM adoption barriers for cryptogenic stroke. Over 100 cardiologists/electrophysiologists and neurologists in the United States reported 70% have significant care pathway challenges; 50% reported no existing care pathway. A clinical need for care pathway creation exists. This study is designed to evaluate the care pathway for patients with a cryptogenic (unknown origin) stroke, large artery atherosclerosis, and small vessel occlusion events in the hospital setting. The intention is to use the results to design another study to further research potential solutions and evaluate the impact on both clinical and economic stroke outcomes.
Who can participate?
Patients aged 18 years or over with a cryptogenic stroke or large artery atherosclerosis or small vessel occlusion hospitalization between 2017 – 2019
What does the study involve?
The study is collecting de-identified data on all subjects who meet the inclusion criteria at participating sites in the United States. Economic and clinical data from initial patient assessment until 180 days after hospitalization will be used to assess cryptogenic stroke, large artery atherosclerosis, and small vessel occlusion hospitalizations to identify potential areas for improvement.
What are the possible benefits and risks of participating?
The study is classified as an observational, non-significant risk study. Because this is a retrospective study in which de-identified data will be collected from participating sites, there are no known or foreseeable risks. The information gained from this study could result in improved cryptogenic stroke care pathways in the future.
Where is this study run from?
Medtronic (USA)
When is the study starting and how long is it expected to run for?
June 2020 to March 2024
Who is funding the study?
Medtronic (USA)
Who is the main contact?
Jessica Mikacevich, jessica.m.mikacevich@medtronic.com
Contact information
Public
8200 Coral Sea Street NE
Mounds View
55112
United States of America
| Phone | +1 (0)952 242 8907 |
|---|---|
| jessica.m.mikacevich@medtronic.com |
Study information
| Study design | Retrospective non-randomized multi-center clinical study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | SeconDary Stroke PreVEntion ThRough Pathway ManagemenT (DiVERT Stroke) |
| Study acronym | DiVERT Stroke |
| Study hypothesis | Current hypothesis as of 29/12/2021: Medtronic will conduct a qualitative and quantitative assessment of cryptogenic stroke, large artery atherosclerosis, and small vessel occlusion hospitalizations at the participating clinical study sites to baseline the current short-term clinical and economic outcomes and identify potential areas for improvement. The intention is to use the results of the Phase I research to design a DiVERT Stroke Phase II study to further investigate and propose potential stroke care pathway solutions that may impact both clinical and economic stroke outcomes. _____ Previous hypothesis: Medtronic will conduct a qualitative and quantitative assessment of cryptogenic stroke hospitalizations at the participating clinical study sites to baseline current short-term clinical and economic outcomes and identify potential areas for improvement. The intention is to use the results of the Phase I research to design a DiVERT Stroke Phase II study to further research potential solutions and evaluate the impact on both clinical and economic stroke outcomes. |
| Ethics approval(s) | Approved 27/12/2020, WCG Institutional Review Board (IRB) (1019 39th Ave SE, Suite 120, Puyallup, WA , Puyallup, 98374, United States of America; +1 (0)855 818 2289 ; clientservices@wcgirb.com), ref: 20203787 Current ethics approval as of 04/10/2022: 1. Approved 01/09/2022, HRA and Health and Care Research Wales (HCRW) (Castlebridge 4, 15-19 Cowbridge Rd E, Cardiff, CF11 9AB, Wales, UK; +44 (0)2920 230457; approvals@hra.nhs.uk, HCRW.approvals@wales.nhs.uk), ref: 22/HRA/3471 2. Approved 27/12/2020, renewed 11/11/2021, WCG Institutional Review Board (IRB) (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 (0)855 818 2289; clientservices@wcgirb.com), ref: 20203787 All centres will seek ethics approval before performing any study-related activities. Site ethics approval may be ceded to WCG Institutional Review Board (IRB). Previous ethics approval: 1. Approved 27/12/2020, WCG Institutional Review Board (IRB) (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 (0)855 818 2289; clientservices@wcgirb.com), ref: 20203787 2. Approved 26/10/2022, WCG Institutional Review Board (IRB) (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 (0)855 818 2289; clientservices@wcgirb.com), ref: 20203787 3. Approved 21/03/2023, WCG Institutional Review Board (IRB) (1019 39th Ave SE, Suite 120, Puyallup, WA 98374, USA; +1 (0)855 818 2289; clientservices@wcgirb.com), ref: 20203787 4. Approved 19/10/2021, CommonSpirit Health Research Institute IRB (198 Inverness Drive West, Englewood, CO 80112, USA; +1 (0)844 626 2299; CHIRB@catholichealth.net) 5. Approved 11/11/2021, CommonSpirit Health Research Institute IRB (198 Inverness Drive West, Englewood, CO 80112, USA; +1 (0)844 626 2299; CHIRB@catholichealth.net) 6. Approved 09/02/2022, CommonSpirit Health Research Institute IRB (198 Inverness Drive West, Englewood, CO 80112, USA; +1 (0)844 626 2299; CHIRB@catholichealth.net) 7. Approved 25/04/2022, CommonSpirit Health Research Institute IRB (198 Inverness Drive West, Englewood, CO 80112, USA; +1 (0)844 626 2299; CHIRB@catholichealth.net) 8. Approved 26/10/2022, CommonSpirit Health Research Institute IRB (198 Inverness Drive West, Englewood, CO 80112, USA; +1 (0)844 626 2299; CHIRB@catholichealth.net) 9. Approved 08/03/2021, USF Research & Innovation - Research Integrity Compliance IRB (3702 Spectrum Blvd, Ste 155, Tampa, FL 33612, USA; +1 (0)813 974 5638; RSCH-arc@usf.edu) 10. Approved 22/06/2021, USF Research & Innovation - Research Integrity Compliance IRB (3702 Spectrum Blvd, Ste 155, Tampa, FL 33612, USA; +1 (0)813 974 5638; RSCH-arc@usf.edu) 11. Approved 01/09/2022, HRA and Health and Care Research Wales (4, 15 - 19 Cowbridge Rd E, Castlebridge, Cardiff CF11 9AB, UK; +44 (0)2920 230457; healthandcareresearch@wales.nhs.uk) |
| Condition | Stroke |
| Intervention | 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 atherosclerosis, and small vessel occlusion patients and the related care pathway. De-identified patient-level data, as outlined below, will be extracted from medical records and hospital cost/charge accounting. This data will be linked with patient-level data from the AHA® Get with the Guidelines® (GWTG) hospital-based quality improvement program to provide a longitudinal view of each patient’s care, outcomes and costs. Additionally, sites will provide Medtronic with documentation of their current stroke care pathways, standard order sets, and other protocols related to stroke patient care. _____ Previous intervention as of 20/05/2021: The DiVERT Stroke Phase I Clinical Study is a retrospective study with a specific focus on collecting data around the stroke and related care pathway. De-identified patient-level data, as outlined below, will be extracted from medical records and hospital cost/charge accounting. This data will be linked with patient-level data from the AHA® Get with the Guidelines® (GWTG) hospital-based quality improvement program to provide a longitudinal view of each patient’s care, outcomes and costs. Additionally, sites will provide Medtronic with documentation of their current stroke care pathways, standard order sets, and other protocols related to stroke patient care. _____ Previous intervention: The DiVERT Stroke Phase I Clinical Study is a retrospective study with a specific focus on collecting data around the cryptogenic stroke and related care pathway. De-identified patient-level data, as outlined below, will be extracted from medical records and hospital cost/charge accounting. This data will be linked with patient-level data from the AHA® Get with the Guidelines® (GWTG) hospital-based quality improvement program to provide a longitudinal view of each patient’s care, outcomes and costs. Additionally, sites will provide Medtronic with documentation of their current stroke care pathways, standard order sets, and other protocols related to stroke patient care. |
| Intervention type | Other |
| Primary outcome measure | 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 hospitalization: 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 information will be collected through medical records and hospital cost/charge accounting data at index stroke hospitalization: 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 information will be collected through medical records and hospital cost/charge accounting data at follow-up visits through 180 days post-index stroke hospitalization (i.e. discharge): 1. Prescribed stroke-related follow-up cadence (office and remote) 2. Stroke-related follow-up dates 3. Neurology diagnostic testing |
| Secondary outcome measures | 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 |
| Overall study start date | 15/06/2020 |
| Overall study end date | 19/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The number of subjects enrolled in this retrospective study will be dependent on the number of subjects at the participating sites that meet the inclusion and exclusion criteria (estimate 7200) |
| Total final enrolment | 6536 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 19/02/2021 |
| Recruitment end date | 20/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- United States of America
Study participating centres
Overland Park
66215
United States of America
Chattanooga
37404
United States of America
Tampa
33606
United States of America
Austin
78705
United States of America
Nashville
37203
United States of America
Charleston
29406
United States of America
Tacoma
98405
United States of America
Federal Way
98003
United States of America
Gig Harbor
98335
United States of America
Silverdale
98383
United States of America
Burien
98166
United States of America
Lakewood
98499
United States of America
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
Industry
8200 Coral Sea Street NE
Mounds View
55112
United States of America
| Phone | +1 (0)612 219 7361 |
|---|---|
| karah.neisen@medtronic.com | |
| Website | http://www.medtronic.com/us-en/index.html |
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medtronic Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 29/12/2021: 1. The protocol and the statistical analysis plan will be publicly available at study completion, or earlier upon request 2. Primary study results will be submitted for publication after the primary objective is met 3. Planned publication targets include: high-impact peer-reviewed journals, neurology conferences, cardiology conferences 4. Planned publication types include but are not limited to: primary publications, ancillary publications, and design publications in the format of manuscripts, abstracts, and posters _____ Previous publication and dissemination plan: 1. Protocol can be sent and the statistical analysis plan will be sent upon completion of the document 2. Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this is a retrospective data pull based on inclusion/exclusion criteria. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 10/07/2024 | 17/07/2024 | No | No |
Additional files
Editorial Notes
17/07/2024: Basic results uploaded.
17/07/2024: The intention to publish date was changed from 26/04/2024 to 31/10/2024.
07/05/2024: The public contact was changed.
10/04/2024: The overall study end date was changed from 20/12/2023 to 19/03/2024.
31/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2022 to 20/12/2023.
2. The overall study end date was changed from 01/04/2023 to 20/12/2023.
3. The intention to publish date was changed from 28/10/2023 to 26/04/2024.
4. The total final enrolment was changed from 7700 to 6536.
23/08/2023: Total final enrolment added.
22/08/2023: The following changes were made to the study record:
1. Ethics approval details added.
2. The overall study end date was changed from 28/04/2023 to 01/04/2023.
04/01/2023: The overall end date was changed from 30/01/2023 to 28/04/2023.
04/10/2022: Ethics approval details added.
30/09/2022: The following changes were made to the trial record:
1. Ethics approval and inclusion criteria updated.
2. United Kingdom and England were added to the countries of recruitment.
3. Franciscan Neurology Associates - Federal Way (St. Francis), Franciscan Neurology Associates - Gig Harbor (St. Anthony), Franciscan Neurology Associates - Silverdale (St. Michael), Franciscan Neurology Associates - Burien (St. Anne), Franciscan Neurology Associates - Lakewood (St. Clare), Northern Care Alliance NHS Foundation Trust were added to the trial participating centres.
12/08/2022: The following changes have been made:
1. The overall trial end date has been changed from 01/12/2022 to 30/01/2023 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 01/08/2022 to 28/10/2023.
04/04/2022: The intention to publish date has been changed from 29/04/2022 to 01/08/2022.
17/03/2022: The overall trial end date has been changed from 01/03/2022 to 01/12/2022 and the plain English summary has been updated accordingly.
31/01/2022: The overall trial end date has been changed from 31/01/2022 to 01/03/2022 and the plain English summary has been updated accordingly.
20/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/01/2022 to 31/01/2022.
2. The ethics approval has been updated.
29/12/2021: The following changes have been made:
1. The study hypothesis has been changed.
2. The ethics approval reference number has been added for the WCG Institutional Review Board approval.
3. The overall trial end date has been changed from 01/01/2022 to 31/01/2022.
4. The intervention has been changed.
5. The primary outcome measures have been changed.
6. The secondary outcome measures have been changed.
7. The Participant inclusion criteria: Target number of participants has been changed from "The number of subjects enrolled in this retrospective study will be dependent on the number of subjects at the site that meet the inclusion and exclusion criteria (estimate 1500)" to "The number of subjects enrolled in this retrospective study will be dependent on the number of subjects at the participating sites that meet the inclusion and exclusion criteria (estimate 7200)" and the target enrolment updated accordingly from 1500 to 7200.
8. CHI Baylor St. Luke’s and Mercy Medical Center have been removed from the trial participating centres and CHI Franciscan Health added.
9. The plain English summary has been changed.
10. The publication and dissemination plan has been changed.
11. The intention to publish date has been changed from 01/07/2022 to 29/04/2022.
28/07/2021: The primary contact was changed.
07/07/2021: The following changes were made to the trial record:
1. The overall end date was changed from 01/07/2021 to 01/01/2022.
2. The recruitment end date was changed from 01/07/2021 to 01/01/2022.
3. The plain English summary was updated to reflect these changes.
20/05/2021: The following changes were made to the trial record:
1. The ethics approval (3) was added.
2. The condition was changed from Cryptogenic stroke to Stroke.
3. The interventions were changed.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
6. The plain English summary was updated to reflect these changes.
10/03/2021: Trial's existence confirmed by the University of South Florida.
