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RecruitingDiabetes Mellitus Type 2Cardiovascular DiseasesCoronary Artery Disease

PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG

Eligible age

40+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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

Sponsor: Aventusoft, LLC.

You may qualify if…

  • ✓ 1. Adult patients older than 40 years of age.
  • ✓ 2. Diagnosis of Type 2 Diabetes Mellitus (insulin dependent or non-insulin dependent) for at least 5 years.
  • ✓ 3. Diagnosis of Cardiovascular Disease (Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease, etc…) --OR--
  • ✓ Have one (1) of the following concomitant medical diagnoses:
  • ✓ 1. Diabetic Retinopathy (proliferative or non-proliferative)
  • ✓ 2. Diabetic Nephropathy (eGFR \<60 mL/min/1.73m2 and/or urine albumin/creatinine ratio ≥30 mg/g)
  • ✓ 3. Diabetic Neuropathy
  • ✓ 4. Elevated High-sensitivity C-reactive protein (hs-CRP) --AND--

You may not qualify if…

  • ✕ 1. Terminal condition with life expectancy less than 12 months as determined by investigator.
  • ✕ 2. Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.
  • ✕ 3. 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).
  • ✕ 4. Participant enrolled in another interventional study (observational or registries are not excluded).
  • ✕ 5. Prisoners and wards of the state.
  • ✕ 6. Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator\'s assessment.
  • ✕ 7. 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.)
  • ✕ 8. Inability to provide informed consent (Must speak English).

Where it's recruiting

Florida

West Palm Beach

Source: ClinicalTrials.gov · NCT06567795 · last updated 2024-08-23

PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients · TrialPath