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| ID | Type | Description | Link |
|---|---|---|---|
| R44HL149561-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEMOTAG with Standard of Care in DM patients | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemotag | Device | Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause hospitalizations | All cause hospitalizations | 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. |
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:
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Any patients that meet inclusion exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CINDY KOBER, BS | Contact | 954-399-3335 | cindy@aventusoft.com | |
| Ali Hamadeh, MS | Contact | 954-399-3335 | ali@aventusoft.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Research Institute, Inc | Recruiting | West Palm Beach | Florida | 33401' | United States |
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| Correlation of AO and CE at 6 and 12 months | Correlation of AO and CE at 6 and 12 months | 12 months |
| Correlation of CTI and CE at 6 and 12 months | Correlation of CTI and CE at 6 and 12 months | 12 months |
| All Deaths for 12 months | All Deaths for 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 | Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months | 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. | 12 months |
| Median time to heart failure at 6 and 12 months | Median time to heart failure at 6 and 12 months | 12 months |
| Median time to Left Ventricular Dysfunction at 6 and 12 months | Median time to Left Ventricular Dysfunction at 6 and 12 months | 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).
| 12 months |
| 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. | 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 | 12 months |
| Treatment Satisfaction | Treatment Satisfaction: Responses are rated on a 7-point scale, ranging from 1 (extremely dissatisfied) to 7 (extremely satisfied). | 12 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| D002561 | Cerebrovascular Disorders |
| D058729 | Peripheral Arterial Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D050197 | Atherosclerosis |
| D016491 | Peripheral Vascular Diseases |
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