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

Recruiting

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

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

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 interval measurements being treated in outpatient clinics. An enriched diabetic patient population, currently undergoing standard medical care for their diabetes management (per the American Diabetes Association) will be invited to participate within this study. All patients will complete their standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL and LDL), HbA1c,and NT-pro BNP, at their regularly scheduled diabetic clinic visits. During the enrollment visit, patients will undergo a baseline HEMOTAG evaluation, cardiovascular event assessment as well as baseline questionnaire assessments. Patients will be shipped a HEMOTAG device with electrodes, and HEMOTAG measurements will be conducted at least three days a week for a 30-day period at-home. This will occur after the Baseline Visit, after the 6-month Visit, and following any hospitalizations due to cardiac events during the 12-month study.

All patients will undergo standard of care follow-up visits at their normal 6 month and 12 month visits and will repeat the HEMOTAG evaluation (in clinic), cardiovascular event assessment, NT-pro BNP, as well as questionnaire assessments. Results of standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL/LDL),and HbA1c, will be collected if performed during their regularly scheduled diabetic clinic visits. Throughout the course of this study, all study participant's medical records will reviewed and assessed for the occurrence of cardiac events (including hospitalizations, emergency room visits/urgent care visits, other cardiac assessments, and death) for up to 12 months. Results from cardiac testing (examples: Echo, Cardiac Catheterization, Stress Tests, etc) that may occur during the 12-month monitoring period will be collected as part of this study.

Study Timeline

• Study Start: 2024-03-14
• Study First Submitted: 2024-05-21
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Primary Completion: 2026-03-18
• Study Completion: 2027-03-18

Recruitment & Eligibility

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

Inclusion Criteria

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--

      Have a history of two (2) or more of the following:

   5. Diagnosis of Hypertension for at least 6 months or more (treated or untreated)

   6. Hypercholesterolemia (LDL-C >100 mg/dL)

   7. Obesity (Body Mass Index (BMI) ≥ 27 for men or ≥ 22 for women)

   8. History of Smoking

4. Willingness to undergo HEMOTAG evaluation.

5. Willingness to undergo Standard of Care visits/assessments and NT-pro BNP lab evaluations.

6. 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.

7. Willingness to receive and return shipping of the HEMOTAG KIT at each time point as required by the protocol

8. Able to give informed consent.

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Exclusion Criteria

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).
9. Women who are pregnant or are planning to become pregnant during the study.
10. Women of childbearing potential who are unwilling or unable to comply with contraception measures.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HEMOTAG with Standard of Care in DM patients	Hemotag	HEMOTAG with Standard of Care: To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.

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.	12 months	The primary endpoint will be to evaluate CV events measured by a composite endpoint defined by unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 12 months.

Secondary Outcome Measures

Name	Time	Method
Median time to Left Ventricular Dysfunction at 6 and 12 months	12 months	Median time to Left Ventricular Dysfunction at 6 and 12 months
Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months	12 months	Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months
Correlation of CTI and CE at 6 and 12 months	12 months	Correlation of CTI and CE at 6 and 12 months
All Deaths for 12 months	12 months	All Deaths for 12 months
Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale)	12 months	Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale) Excellent: Distance is typically above 700 meters. Good: Distances within the average range between 400 and 700 meters Poor: Distances below the average range, indicating potential limitations in aerobic capacity and functional status is below 400 meters.
Median time to heart failure at 6 and 12 months	12 months	Median time to heart failure at 6 and 12 months
Health State as measured by the EQ5D5L ( EuroQol 5 Dimensions 5 Levels)	12 months	Health State as measured by the EQ5D5L: 1 is the best possible value (indicating no problems), and 5 is the worst (indicating extreme problems).; 1. indicates no problems; 2. indicates slight problems; 3. indicates moderate problems; 4. indicates severe problems; 5. indicates extreme problems
Secondary objective will evaluate various cardiac events occurring over time throughout the observational period as well as quality of life measurements for 6 months.	6 months	Composite endpoint consisting of unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 6 months.
Correlation of AO and CE at 6 and 12 months	12 months	Correlation of AO and CE at 6 and 12 months

Trial Locations

Locations (1)

Metabolic Research Institute, Inc; 🇺🇸 West Palm Beach, Florida, United States