PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Part of paid clinical trials in West Palm Beach, Florida.
- Sponsor
- Aventusoft, LLC.
- Study ID
- NCT06567795
- Status
- Recruiting
Conditions
- Cardiovascular Diseases
- Cerebrovascular Disease
- Coronary Artery Disease
- Diabetes Mellitus Type 2
- Peripheral Artery Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Hemotag — DEVICEHemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days
Study Details
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
Key Dates
- Start date
- Mar 14, 2024
- Status verified
- Aug 2024
- Primary completion
- Mar 18, 2026
- Completion
- Mar 18, 2027
Study Design
- Enrollment
- 189 participants (estimated)
Arms
- Arm: HEMOTAG with Standard of Care in DM patientsHEMOTAG with Standard of Care: To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.
Primary Outcome Measure
To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration. [ Time Frame: 12 months ]
Central Contacts
- CINDY KOBER, BS954-399-3335
- Ali Hamadeh, MS954-399-3335
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Metabolic Research Institute, Inc | West Palm Beach | Florida | 33401' | Barry Horowitz, MD (PRINCIPAL_INVESTIGATOR) |
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