Actively Recruiting
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Led by Aventusoft, LLC. · Updated on 2024-08-23
189
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
A
Aventusoft, LLC.
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
CONDITIONS
Official Title
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients older than 40 years of age.
- Diagnosis of Type 2 Diabetes Mellitus (insulin dependent or non-insulin dependent) for at least 5 years.
- Diagnosis of Cardiovascular Disease (Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease) or presence of one of the following: diabetic retinopathy, diabetic nephropathy (eGFR <60 mL/min/1.73m2 or urine albumin/creatinine ratio 630 mg/g), diabetic neuropathy, or elevated high-sensitivity C-reactive protein.
- History of two or more of the following: hypertension for at least 6 months, hypercholesterolemia (LDL-C >100 mg/dL), obesity (BMI 27 for men or 22 for women), or history of smoking.
- Willingness to undergo HEMOTAG evaluation.
- Willingness to undergo standard care visits and NT-pro BNP testing.
- Willingness to perform at-home HEMOTAG measurements at least three days per week for 30 days after baseline, 6-month visits, and after cardiac hospitalizations during the 12-month study.
- Willingness to receive and return the HEMOTAG device as required.
- Able to give informed consent.
You will not qualify if you...
- Terminal condition with life expectancy less than 12 months.
- Physical deformity or lesion on the chest that prevents proper HEMOTAG use.
- Illness or condition causing significant discomfort with HEMOTAG application (e.g., skin issues or electrode intolerance).
- Currently enrolled in another interventional study (observational studies allowed).
- Prisoners or wards of the state.
- Impaired cognitive ability or other conditions preventing compliance.
- Unable to provide informed, voluntary consent (including need for legally authorized representative).
- Unable to provide informed consent in English.
- Pregnant women or those planning pregnancy during the study.
- Women of childbearing potential unwilling or unable to follow contraception requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Metabolic Research Institute, Inc
West Palm Beach, Florida, United States, 33401'
Actively Recruiting
Research Team
C
CINDY KOBER, BS
CONTACT
A
Ali Hamadeh, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here