PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
NCT Number: NCT06567795
Acronym: PRIZETAG
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetes Mellitus Type 2|Cardiovascular Diseases|Coronary Artery Disease|Cerebrovascular Disease|Peripheral Artery Disease
Interventions: DEVICE: Hemotag
Sponsor: Aventusoft, LLC.
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 189
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-14
Completion Date: 2027-03-18
Locations: Metabolic Research Institute, Inc, West Palm Beach, Florida, 33401', United States

Summary:
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.

Primary Outcome Measures: To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration., The primary endpoint will be to evaluate CV events measured by a composite endpoint defined by unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 12 months., 12 months
Secondary Outcome Measures: Secondary objective will evaluate various cardiac events occurring over time throughout the observational period as well as quality of life measurements for 6 months., Composite endpoint consisting of unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 6 months., 6 months|Correlation of AO and CE at 6 and 12 months, Correlation of AO and CE at 6 and 12 months, 12 months|Correlation of CTI and CE at 6 and 12 months, Correlation of CTI and CE at 6 and 12 months, 12 months|All Deaths for 12 months, All Deaths for 12 months, 12 months|Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months, Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months, 12 months|Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale), Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale) Excellent: Distance is typically above 700 meters. Good: Distances within the average range between 400 and 700 meters Poor: Distances below the average range, indicating potential limitations in aerobic capacity and functional status is below 400 meters., 12 months|Median time to heart failure at 6 and 12 months, Median time to heart failure at 6 and 12 months, 12 months|Median time to Left Ventricular Dysfunction at 6 and 12 months, Median time to Left Ventricular Dysfunction at 6 and 12 months, 12 months|Health State as measured by the EQ5D5L ( EuroQol 5 Dimensions 5 Levels), Health State as measured by the EQ5D5L: 1 is the best possible value (indicating no problems), and 5 is the worst (indicating extreme problems).

1. indicates no problems
2. indicates slight problems
3. indicates moderate problems
4. indicates severe problems
5. indicates extreme problems, 12 months
Other Outcome Measures: All cause hospitalizations, All cause hospitalizations, 12 months|Health Status as measured by the LVD-36, Health Status as measured by the LVD-36 Low Scores: Indicate fewer symptoms and better quality of life. High Scores: Indicate more severe symptoms and poorer quality of life., 12 months|Productivity questionnaire, Productivity questions deal with how health issues or their treatment have affected the subject's ability to remain in the workforce and perform daily activities in the home., 12 months|Health care resource utilization, Health care resource utilization Frequency of visits to the emergency department within 30 days Rates of patients being readmitted to the hospital within a 30 day time period. Reporting of outpatient visits within 30 days, 12 months|Treatment Satisfaction, Treatment Satisfaction: Responses are rated on a 7-point scale, ranging from 1 (extremely dissatisfied) to 7 (extremely satisfied)., 12 months