NCT06567795 · Aventusoft, LLC.
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
(PRIZETAG)
What this study is about
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
View original scientific description
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- West Palm Beach, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 23, 2024 · Source of record for eligibility and locations