RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG

Quick Facts

Study Start:2024-03-14

Study Completion:2027-03-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06567795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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-- 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-- 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.	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.

Inclusion Criteria

Exclusion 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--
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--
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.

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.

Contacts and Locations

Study Contact

CINDY KOBER, BS

CONTACT

954-399-3335

cindy@aventusoft.com

Ali Hamadeh, MS

CONTACT

954-399-3335

ali@aventusoft.com

Study Locations (Sites)

Metabolic Research Institute, Inc

West Palm Beach, Florida, 33401'

United States

Collaborators and Investigators

Sponsor: Aventusoft, LLC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-14

Study Completion Date2027-03-18

Study Record Updates

Study Start Date2024-03-14

Study Completion Date2027-03-18

Terms related to this study

Keywords Provided by Researchers

Diabetes Mellitus
Cardiovascular Diseases
Coronary Artery Disease

Additional Relevant MeSH Terms

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