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

Recruiting

• Conditions: Diabetes Mellitus Type 2; Cardiovascular Diseases; Coronary Artery Disease; Cerebrovascular Disease; Peripheral Artery Disease

• Registration Number: NCT06567795
• Lead Sponsor: Aventusoft, LLC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Adult patients older than 40 years of age.<br><br> 2. Diagnosis of Type 2 Diabetes Mellitus (insulin dependent or non-insulin dependent)<br> for at least 5 years.<br><br> 3. Diagnosis of Cardiovascular Disease (Coronary Artery Disease, Cerebrovascular<br> Disease, Peripheral Artery Disease, etc...) --OR--<br><br> Have one (1) of the following concomitant medical diagnoses:<br><br> 1. Diabetic Retinopathy (proliferative or non-proliferative)<br><br> 2. Diabetic Nephropathy (eGFR <60 mL/min/1.73m2 and/or urine albumin/creatinine<br> ratio =30 mg/g)<br><br> 3. Diabetic Neuropathy<br><br> 4. Elevated High-sensitivity C-reactive protein (hs-CRP) --AND--<br><br> Have a history of two (2) or more of the following:<br><br> 5. Diagnosis of Hypertension for at least 6 months or more (treated or untreated)<br><br> 6. Hypercholesterolemia (LDL-C >100 mg/dL)<br><br> 7. Obesity (Body Mass Index (BMI) = 27 for men or = 22 for women)<br><br> 8. History of Smoking<br><br> 4. Willingness to undergo HEMOTAG evaluation.<br><br> 5. Willingness to undergo Standard of Care visits/assessments and NT-pro BNP lab<br> evaluations.<br><br> 6. Willingness to conduct at-home HEMOTAG evaluations at least three days per week<br> within a 30-day time period after the completion of the Baseline Visit, after the 6<br> month visit and following discharge from any hospitalizations due to a cardiac<br> events during the 12 month study period.<br><br> 7. Willingness to receive and return shipping of the HEMOTAG KIT at each time point as<br> required by the protocol<br><br> 8. Able to give informed consent.<br><br>Exclusion Criteria:<br><br> 1. Terminal condition with life expectancy less than 12 months as determined by<br> investigator.<br><br> 2. Physical deformity in the chest area or lesion that may prevent proper HEMOTAG<br> application or adjustment.<br><br> 3. Illness/ Condition which may be aggravated or cause significant discomfort to the<br> patient by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of<br> skin electrodes).<br><br> 4. Participant enrolled in another interventional study (observational or registries<br> are not excluded).<br><br> 5. Prisoners and wards of the state.<br><br> 6. Impaired cognitive ability or any other state that may prevent full compliance with<br> the study protocol, according to investigator's assessment.<br><br> 7. Participants unable to provide informed, voluntary decision to participate in<br> research study as determined by the investigator. (Exclude participants who<br> necessitate the involvement of a legally authorized representative.)<br><br> 8. Inability to provide informed consent (Must speak English).<br><br> 9. Women who are pregnant or are planning to become pregnant during the study.<br><br> 10. Women of childbearing potential who are unwilling or unable to comply with<br> contraception measures.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.

Secondary Outcome Measures

Name	Time	Method
Secondary objective will evaluate various cardiac events occurring over time throughout the observational period as well as quality of life measurements for 6 months.;Correlation of AO and CE at 6 and 12 months;Correlation of CTI and CE at 6 and 12 months;All Deaths for 12 months;Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months;Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale);Median time to heart failure at 6 and 12 months;Median time to Left Ventricular Dysfunction at 6 and 12 months;Health State as measured by the EQ5D5L ( EuroQol 5 Dimensions 5 Levels)