Status:
RECRUITING
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Lead Sponsor:
Aventusoft, LLC.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes Mellitus Type 2
Cardiovascular Diseases
Eligibility:
All Genders
40+ years
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 inte...
Eligibility Criteria
Inclusion
- 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, etc…) --OR--
- Have one (1) of the following concomitant medical diagnoses:
- Diabetic Retinopathy (proliferative or non-proliferative)
- Diabetic Nephropathy (eGFR \<60 mL/min/1.73m2 and/or urine albumin/creatinine ratio ≥30 mg/g)
- Diabetic Neuropathy
- Elevated High-sensitivity C-reactive protein (hs-CRP) --AND--
- Have a history of two (2) or more of the following:
- Diagnosis of Hypertension for at least 6 months or more (treated or untreated)
- Hypercholesterolemia (LDL-C \>100 mg/dL)
- Obesity (Body Mass Index (BMI) ≥ 27 for men or ≥ 22 for women)
- History of Smoking
- Willingness to undergo HEMOTAG evaluation.
- Willingness to undergo Standard of Care visits/assessments and NT-pro BNP lab evaluations.
- Willingness to conduct at-home HEMOTAG evaluations at least three days per week within a 30-day time period after the completion of the Baseline Visit, after the 6 month visit and following discharge from any hospitalizations due to a cardiac events during the 12 month study period.
- Willingness to receive and return shipping of the HEMOTAG KIT at each time point as required by the protocol
- Able to give informed consent.
Exclusion
- Terminal condition with life expectancy less than 12 months as determined by investigator.
- Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.
- Illness/ Condition which may be aggravated or cause significant discomfort to the patient by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes).
- Participant enrolled in another interventional study (observational or registries are not excluded).
- Prisoners and wards of the state.
- Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator\'s assessment.
- Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.)
- Inability to provide informed consent (Must speak English).
- Women who are pregnant or are planning to become pregnant during the study.
- Women of childbearing potential who are unwilling or unable to comply with contraception measures.
Key Trial Info
Start Date :
March 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 18 2027
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT06567795
Start Date
March 14 2024
End Date
March 18 2027
Last Update
August 23 2024
Active Locations (1)
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1
Metabolic Research Institute, Inc
West Palm Beach, Florida, United States, 33401'