An observational study in Diabetes Mellitus Type 2, Cardiovascular Diseases and Coronary Artery Disease, sponsored by Aventusoft, LLC.. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Aventusoft, LLC. · Observational
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
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.
374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.
This study's planned enrollment of 189 is below the median of 443 across 135 observational studies indexed under Cerebrovascular Disorders.
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Counted across the registry records on this site, refreshed daily.
Any patients that meet inclusion exclusion criteria
Diagnosis of Cardiovascular Disease (Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease, etc...) --OR--
Have one (1) of the following concomitant medical diagnoses:
Elevated High-sensitivity C-reactive protein (hs-CRP) --AND--
Have a history of two (2) or more of the following:
Exclusion Criteria:
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.
Device: Hemotag
Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days
To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.
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.
Time frame: 12 months
Secondary objective will evaluate various cardiac events occurring over time throughout the observational period as well as quality of life measurements for 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.
Time frame: 6 months
Correlation of AO and CE at 6 and 12 months
Correlation of AO and CE at 6 and 12 months
Time frame: 12 months
Correlation of CTI and CE at 6 and 12 months
Correlation of CTI and CE at 6 and 12 months
Time frame: 12 months
All Deaths for 12 months
All Deaths for 12 months
Time frame: 12 months
Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months
Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months
Time frame: 12 months
Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale)
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.
Time frame: 12 months
Median time to heart failure at 6 and 12 months
Median time to heart failure at 6 and 12 months
Time frame: 12 months
Median time to Left Ventricular Dysfunction at 6 and 12 months
Median time to Left Ventricular Dysfunction at 6 and 12 months
Time frame: 12 months
Health State as measured by the EQ5D5L ( EuroQol 5 Dimensions 5 Levels)
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
Time frame: 12 months
All cause hospitalizations
All cause hospitalizations
Time frame: 12 months
Health Status as measured by the LVD-36
Health Status as measured by the LVD-36 Low Scores: Indicate fewer symptoms and better quality of life. High Scores: Indicate more severe symptoms and poorer quality of life.
Time frame: 12 months
Productivity questionnaire
Productivity questions deal with how health issues or their treatment have affected the subject's ability to remain in the workforce and perform daily activities in the home.
Time frame: 12 months
Health care resource utilization
Health care resource utilization Frequency of visits to the emergency department within 30 days Rates of patients being readmitted to the hospital within a 30 day time period. Reporting of outpatient visits within 30 days
Time frame: 12 months
Treatment Satisfaction
Treatment Satisfaction: Responses are rated on a 7-point scale, ranging from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Time frame: 12 months
Plan to share: No
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