Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567795
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-21
Brief Title:
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Sponsor:
None
Organization:
None
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:
No
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 HbA1cand 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 HDLLDLand HbA1c will be collected if performed during their regularly scheduled diabetic clinic visits Throughout the course of this study all study participants medical records will reviewed and assessed for the occurrence of cardiac events including hospitalizations emergency room visitsurgent 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 HDLLDLand HbA1c will be collected if performed during their regularly scheduled diabetic clinic visits Throughout the course of this study all study participants medical records will reviewed and assessed for the occurrence of cardiac events including hospitalizations emergency room visitsurgent 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None