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

NCT06567795 | Recruiting DMC FDA Device

• 2 other identifiers: HT-101-VV-032R44HL149561-03
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.

Conditions

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

Keywords

Diabetes Mellitus; Cardiovascular Diseases; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

• Correlation of AO and CE at 6 and 12 months

  12 months

• Correlation of CTI and CE at 6 and 12 months

  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

  12 months

Other Outcomes (5)

• All cause hospitalizations

  12 months

• Health Status as measured by the LVD-36

  12 months

• Productivity questionnaire

  12 months

Study Arms (1)

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.

Device: Hemotag

Interventions

Hemotag DEVICE

Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days

HEMOTAG with Standard of Care in DM patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patients that meet inclusion exclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aventusoft, LLC.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Metabolic Research Institute, Inc

West Palm Beach, Florida, 33401', United States

RECRUITING

Related Links

• website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Coronary Artery Disease; Cerebrovascular Disorders; Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Atherosclerosis; Peripheral Vascular Diseases

Central Study Contacts

CINDY KOBER, BS

CONTACT

954-399-3335; cindy@aventusoft.com

Ali Hamadeh, MS

CONTACT

954-399-3335; ali@aventusoft.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: August 23, 2024
• Study Start: March 14, 2024
• Primary Completion: March 18, 2026
• Study Completion (Estimated): March 18, 2027
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)