Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04836117
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2021-04-05
Brief Title:
Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients at Higher Risk of Cardiovascular Disease A Feasibility and an Adaptive Implementation Study
Sponsor:
Intermountain Health Care Inc
Organization:
Intermountain Health Care Inc
Study Overview
Official Title:
Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients at Higher Risk of Cardiovascular Disease A Feasibility and an Adaptive Implementation Study SomaSignal Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SomaSignal
Brief Summary:
Feasibility Study Informed consent will be obtained using an IRB-approved form The first 12 consenting patients will be placed in the planned assessment group for feasibility and will not be randomized These participants will undergo visits and blood draw collection at 3 months They will be informed of their SomaSignal Test results at baseline and 3 months
Recommendations for any medical management changes will be made based on an understanding of those results
Randomized Study The succeeding 200 participants will be randomized using permuted mixed block randomization in a 21 ratio ie 2 participants to Group 1 informed of their test results and 1 participant to Group 2 uninformed of their test results At enrollment and for 6 months thereafter clinical information will be obtained from each participants medical records andor directly from the participant during procedures treatments study-specific visits andor follow-up visits Data collected for the study will have data linkage at SomaLogic Inc where data analysis will be done
At baseline and 6-months 30 days post-enrollment patients will undergo a patient visit and blood collection Blood will be collected as a stand-alone sample collection or when other ordered lab work is done or from access lines inserted during a usual or specialized care Samples will be sent to the Intermountain Central laboratory for clinical testing A sample will also be processed and shipped to SomaLogic Inc for analysis at baseline and 6 months
For the informed arm the SomaSignal Test reports will be provided at the time they are available 2 to 4 weeks after the blood draw Any recommended changes in medical management will be recorded in the case report forms and will be verified by the Principal Investigator
For the uninformed arm the SomaSignal Test results will not be provided to the study team until after the 6-month post-test visit Adjustments if any would be made to the participants management at that time
Recommendations for any medical management changes will be made based on an understanding of those results
Randomized Study The succeeding 200 participants will be randomized using permuted mixed block randomization in a 21 ratio ie 2 participants to Group 1 informed of their test results and 1 participant to Group 2 uninformed of their test results At enrollment and for 6 months thereafter clinical information will be obtained from each participants medical records andor directly from the participant during procedures treatments study-specific visits andor follow-up visits Data collected for the study will have data linkage at SomaLogic Inc where data analysis will be done
At baseline and 6-months 30 days post-enrollment patients will undergo a patient visit and blood collection Blood will be collected as a stand-alone sample collection or when other ordered lab work is done or from access lines inserted during a usual or specialized care Samples will be sent to the Intermountain Central laboratory for clinical testing A sample will also be processed and shipped to SomaLogic Inc for analysis at baseline and 6 months
For the informed arm the SomaSignal Test reports will be provided at the time they are available 2 to 4 weeks after the blood draw Any recommended changes in medical management will be recorded in the case report forms and will be verified by the Principal Investigator
For the uninformed arm the SomaSignal Test results will not be provided to the study team until after the 6-month post-test visit Adjustments if any would be made to the participants management at that time
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None