RECRUITING

A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events

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Conditions

Diabetes Mellitus, Type 2PreDiabetesMetabolic Syndrome

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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

TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.

Official Title

A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events

Quick Facts

Study Start:2024-03-06
Study Completion:2029-03-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06112418

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:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provided electronic or written informed consent
  2. 2. Men \> 55, women \> 65 years of age
  3. 3. Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and/or fasting glucose 100-125 mg/dL \[5.6-6.9 mmol/L\]) and/or metabolic syndrome. Metabolic syndrome is defined as \> 3 of the following criteria (International Diabetes Federation 2006):
  4. * Body mass index ≥ 27 kg/m2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)
  5. * Fasting triglycerides ≥ 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia
  6. * HDL-cholesterol (HDL-C) \< 40 mg/dL (1.03 mmol/L) in men, \<50 mg/dL (1.29 mmol/L) in women or treatment for this lipid abnormality
  7. * Systolic blood pressure (BP) ≥ 130 and/or diastolic BP≥ 85 mm Hg and/or treated hypertension
  8. * Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or HbA1c ≥ 5.7%
  9. 4. Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group
  1. 1. History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure
  2. 2. Planned arterial revascularization
  3. 3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:
  4. 1. eGFR \< 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org/professionals/kdoqi/gfr_calculator)
  5. 2. Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.
  6. 3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment
  7. 4. Weight \> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site
  8. 5. Inability to hold breath for \> 10 seconds
  9. 6. Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \> 80 beats per minute at screening or prior to CCTA)
  10. 7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA
  11. 8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA
  12. 4. Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \< 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)

Contacts and Locations

Study Contact

Ryann Sardinia
CONTACT
7205931599
ryann.sardinia@cleerlyhealth.com
Ashley Dunham, PhD
CONTACT
7205931599
ashley.dunham@cleerlyhealth.com

Principal Investigator

Deepak Bhatt, MD, MPH
STUDY_CHAIR
Mt. Sinai Heart

Study Locations (Sites)

Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
United States
Sun City Research
Sun City, Arizona, 85381
United States
Noble Clinical Research
Tucson, Arizona, 85704
United States
Amicis Research: Beverly Hills
Beverly Hills, California, 90211
United States
Valiance Clinical Research - Canoga Park
Canoga Park, California, 91303
United States
Cardiovascular Institute of San Diego
Chula Vista, California, 91911
United States
Amicis Research: Granada Hills
Granada Hills, California, 91324
United States
Valiance Clinical Research: Huntington Park
Huntington Park, California, 90255
United States
Long Beach Research Institute
Long Beach, California, 90805
United States
Amicis Research: Newhall
Newhall, California, 91321
United States
Ace Research Institute: Northridge
Northridge, California, 91324
United States
Amicis Research: Northridge
Northridge, California, 91324
United States
Ace Research Institute: Northridge #2
Northridge, California, 91325
United States
Northridge Clinical Trials
Northridge, California, 91325
United States
Amicis Research: San Fernando
San Fernando, California, 91306
United States
Valiance Clinical Research - Tarzana
Tarzana, California, 91356
United States
Amicis Research: Valencia
Valencia, California, 91355
United States
University of Colorado
Aurora, Colorado, 80045
United States
Flourish Medical Research
Boca Raton, Florida, 33434
United States
Evolution Research Center
Hialeah, Florida, 33012
United States
UF Health Jacksonville
Jacksonville, Florida, 32209
United States
Fiel Wellness Clinical Research LLC
Miami, Florida, 33135
United States
BioPhase Research
Miami, Florida, 33137
United States
United Clinical Research
Miami, Florida, 33155
United States
Atlantis Clinical Research, LLC
Miami, Florida, 33173
United States
Farma Medical Inc.
Miami, Florida, 33183
United States
Ascension Sacred Heart
Pensacola, Florida, 32504
United States
Indiana Medical Research Institute
Indianapolis, Indiana, 46202
United States
Franciscan Physician Network- Indiana Heart Physicians
Indianapolis, Indiana, 46237
United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50266
United States
UofL Health
Louisville, Kentucky, 40202
United States
Flourish Bowie dba Flourish Research
Bowie, Maryland, 20715
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Boeson Research Fort Missoula
Missoula, Montana, 59804
United States
Bryan Heart
Lincoln, Nebraska, 68506
United States
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, 08822
United States
Virtua Health, Inc.
Marlton, New Jersey, 08053
United States
Rutgers State University
New Brunswick, New Jersey, 08901
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
Clindove Research
Brooklyn, New York, 11221
United States
Swift Clinical Research
Brooklyn, New York, 11226
United States
Northwell Health Northern Westchester Hospital
Mount Kisco, New York, 10549
United States
West Clinical Research
Morehead City, North Carolina, 28557
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Medical Research International, LLC
Oklahoma City, Oklahoma, 73109
United States
Ascension St. John - Jane Phillips Medical Center
Tulsa, Oklahoma, 74104
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
TriStar Centennial Medical Center (HCA Health Care)
Nashville, Tennessee, 37202
United States
Hendrick Health
Abilene, Texas, 79601
United States
Gadolin Research
Beaumont, Texas, 77702
United States
Helium Research Group
Houston, Texas, 77004
United States
Kelsey Research Foundation
Houston, Texas, 77025
United States
Gulf Coast Clinical Research, LLC
Houston, Texas, 77070
United States
North Dallas Research Associates - Kerlo Network
McKinney, Texas, 75069
United States
SMS Clinical Research
Mesquite, Texas, 75149
United States
Chippenham Johnston Willis Medical Center
Richmond, Virginia, 23225
United States
Charleston Area Medical Center
Charleston, West Virginia, 25304
United States

Collaborators and Investigators

Sponsor: Cleerly, Inc.

  • Deepak Bhatt, MD, MPH, STUDY_CHAIR, Mt. Sinai Heart

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 Date2024-03-06
Study Completion Date2029-03-05

Study Record Updates

Study Start Date2024-03-06
Study Completion Date2029-03-05

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Metabolic Syndrome