Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-24 @ 7:13 PM
Study NCT ID:
NCT06567795
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Sponsor:
Aventusoft, LLC.
Organization:
Study Overview
Official Title:
Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PRIZETAG
Brief Summary:
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
Detailed Description:
This is a prospective, multi-center, longitudinal study to evaluate the proportion of cardiovascular events in diabetic mellitus patients identified by HEMOTAG evaluations, utilizing cardiac time interval measurements being treated in outpatient clinics. An enriched diabetic patient population, currently undergoing standard medical care for their diabetes management (per the American Diabetes Association) will be invited to participate within this study. All patients will complete their standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL and LDL), HbA1c,and NT-pro BNP, at their regularly scheduled diabetic clinic visits. During the enrollment visit, patients will undergo a baseline HEMOTAG evaluation, cardiovascular event assessment as well as baseline questionnaire assessments. Patients will be shipped a HEMOTAG device with electrodes, and HEMOTAG measurements will be conducted at least three days a week for a 30-day period at-home. This will occur after the Baseline Visit, after the 6-month Visit, and following any hospitalizations due to cardiac events during the 12-month study.
All patients will undergo standard of care follow-up visits at their normal 6 month and 12 month visits and will repeat the HEMOTAG evaluation (in clinic), cardiovascular event assessment, NT-pro BNP, as well as questionnaire assessments. Results of standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL/LDL),and HbA1c, will be collected if performed during their regularly scheduled diabetic clinic visits. Throughout the course of this study, all study participant's medical records will reviewed and assessed for the occurrence of cardiac events (including hospitalizations, emergency room visits/urgent care visits, other cardiac assessments, and death) for up to 12 months. Results from cardiac testing (examples: Echo, Cardiac Catheterization, Stress Tests, etc) that may occur during the 12-month monitoring period will be collected as part of this study.
All patients will undergo standard of care follow-up visits at their normal 6 month and 12 month visits and will repeat the HEMOTAG evaluation (in clinic), cardiovascular event assessment, NT-pro BNP, as well as questionnaire assessments. Results of standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL/LDL),and HbA1c, will be collected if performed during their regularly scheduled diabetic clinic visits. Throughout the course of this study, all study participant's medical records will reviewed and assessed for the occurrence of cardiac events (including hospitalizations, emergency room visits/urgent care visits, other cardiac assessments, and death) for up to 12 months. Results from cardiac testing (examples: Echo, Cardiac Catheterization, Stress Tests, etc) that may occur during the 12-month monitoring period will be collected as part of this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44HL149561-03 | NIH | None | https://reporter.nih.gov/quic… | View |