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

Status: Recruiting
Location: See all (103) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: t
View:

• Provided electronic or written informed consent

• Men \> 55, women \> 65 years of age

• 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):

‣ 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)

⁃ Fasting triglycerides ≥ 150 mg/dL (1.7 mmol/L) or treated hypertriglyceridemia

⁃ 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

⁃ Systolic blood pressure (BP) ≥ 130 and/or diastolic BP≥ 85 mm Hg and/or treated hypertension

⁃ Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or HbA1c ≥ 5.7%

• Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group

Locations
United States
Arizona
Chandler Clinical Trials
RECRUITING
Chandler
Scottsdale Clinical Trials
RECRUITING
Scottsdale
Sun City Research
RECRUITING
Sun City
Noble Clinical Research
RECRUITING
Tucson
California
Amicis Research: Beverly Hills
RECRUITING
Beverly Hills
Cardiovascular Research Foundation of Southern California
RECRUITING
Beverly Hills
Valiance Clinical Research - Canoga Park
RECRUITING
Canoga Park
Cardiovascular Institute of San Diego
RECRUITING
Chula Vista
Amicis Research: Granada Hills
RECRUITING
Granada Hills
Valiance Clinical Research: Huntington Park
RECRUITING
Huntington Park
Chemidox Clinical Trials
RECRUITING
Lancaster
Long Beach Research Institute
RECRUITING
Long Beach
Ace Research Institute - Monterey Park
RECRUITING
Monterey Park
Amicis Research: Newhall
RECRUITING
Newhall
Ace Research Institute: Northridge
RECRUITING
Northridge
Ace Research Institute: Northridge #2
RECRUITING
Northridge
Amicis Research: Northridge
RECRUITING
Northridge
Northridge Clinical Trials
RECRUITING
Northridge
Stanford Health Care
RECRUITING
Palo Alto
VA Palo Alto
RECRUITING
Palo Alto
Amicis Research: San Fernando
RECRUITING
San Fernando
Valiance Clinical Research - Tarzana
RECRUITING
Tarzana
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
RECRUITING
Torrance
Amicis Research: Valencia
RECRUITING
Valencia
Colorado
University of Colorado
RECRUITING
Aurora
St. Josephs (Intermountain Healthcare)
RECRUITING
Denver
Florida
Flourish Medical Research
RECRUITING
Boca Raton
Apex Research
RECRUITING
Cross City
Evolution Research Center
RECRUITING
Hialeah
UF Health Jacksonville
RECRUITING
Jacksonville
Atlantis Clinical Research, LLC
RECRUITING
Miami
Baptist Health Miami Cardiac and Vascular Institute
RECRUITING
Miami
BioPhase Research
RECRUITING
Miami
Farma Medical Inc.
RECRUITING
Miami
Fiel Wellness Clinical Research LLC
RECRUITING
Miami
New Access Research and Medical Center
RECRUITING
Miami
United Clinical Research
RECRUITING
Miami
Quantum Clinical Trials
RECRUITING
Miami Beach
Ascension Sacred Heart
RECRUITING
Pensacola
Clinical Research Center of Florida
RECRUITING
Pompano Beach
University of South Florida
RECRUITING
Tampa
Georgia
Aiyan Diabetes Center
RECRUITING
Augusta
Emory University
RECRUITING
Dunwoody
Peachtree Clinical Solutions - Noir Research Collective
RECRUITING
Powder Springs
Randomize Now, LLC - Noir Research Collective
RECRUITING
Riverdale
Iowa
MercyOne Iowa Heart Center
RECRUITING
West Des Moines
Idaho
Care Institute- High Desert
RECRUITING
Meridian
Illinois
Northshore University Health System
RECRUITING
Evanston
Indiana
Franciscan Physician Network- Indiana Heart Physicians
RECRUITING
Indianapolis
Indiana Medical Research Institute
RECRUITING
Indianapolis
Kentucky
St Elizabeth Health Care - CRI
RECRUITING
Edgewood
UofL Health
RECRUITING
Louisville
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Flourish Bowie dba Flourish Research
RECRUITING
Bowie
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Missouri
Saint Louis Heart and Vascular
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Montana
Boeson Research Kalispell
RECRUITING
Kalispell
Boeson Research Fort Missoula
RECRUITING
Missoula
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Duke University Hospital
RECRUITING
Durham
West Clinical Research
RECRUITING
Morehead City
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Nebraska
Bryan Heart
RECRUITING
Lincoln
New Jersey
Advanced Heart and Vascular Institute of Hunterdon
RECRUITING
Flemington
Virtua Health, Inc.
RECRUITING
Marlton
Rutgers State University
RECRUITING
New Brunswick
The Valley Hospital
RECRUITING
Paramus
Holy Name Medical Center
RECRUITING
Teaneck
Nevada
Southwest Medical Associates- Optum Nevada
RECRUITING
Las Vegas
Vector Clinical Trials
RECRUITING
Las Vegas
New York
Clindove Research
RECRUITING
Brooklyn
Swift Clinical Research
RECRUITING
Brooklyn
Rasaj Research
RECRUITING
Jackson Heights
Optum- Long Island NY
RECRUITING
Lake Success
Northwell Health Northern Westchester Hospital
RECRUITING
Mount Kisco
Mount Sinai
RECRUITING
New York
Mount Sinai West
RECRUITING
New York
Ohio
Summa Health
RECRUITING
Akron
Oklahoma
Hightower Clinical
RECRUITING
Oklahoma City
Medical Research International, LLC
RECRUITING
Oklahoma City
Ascension St. John - Jane Phillips Medical Center
RECRUITING
Tulsa
Pennsylvania
Capital Area Research
RECRUITING
Camp Hill
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Community DPC
RECRUITING
Cleveland
University of Tennessee Medical Center
RECRUITING
Knoxville
TriStar Centennial Medical Center (HCA Health Care)
RECRUITING
Nashville
Texas
Hendrick Health
RECRUITING
Abilene
Gadolin Research
RECRUITING
Beaumont
CardioVoyage, LLC
RECRUITING
Greenville
Gulf Coast Clinical Research, LLC
RECRUITING
Houston
Helium Research Group
RECRUITING
Houston
Kelsey Research Foundation
RECRUITING
Houston
The Methodist Hospital, DeBakey Cardiology Associates
RECRUITING
Houston
Aeres Clinical Research
RECRUITING
Laredo
DC Clinical Research
RECRUITING
Lewisville
North Dallas Research Associates - Kerlo Network
RECRUITING
Mckinney
SMS Clinical Research
RECRUITING
Mesquite
Privia Medical Group- North Texas
RECRUITING
Stephenville
Virginia
Chippenham Johnston Willis Medical Center
RECRUITING
Richmond
West Virginia
Charleston Area Medical Center
RECRUITING
Charleston
Contact Information
Primary
Ryann Sardinia
ryann.sardinia@cleerlyhealth.com
7207398191
Backup
Ashley Dunham, PhD
ashley.dunham@cleerlyhealth.com
7207398191
Time Frame
Start Date: 2024-03-06
Estimated Completion Date: 2029-03-05
Participants
Target number of participants: 7500
Treatments
No_intervention: Risk Factor-Based Care
The risk factor-based care group will be managed by their usual care providers, with an initial pre-randomization assessment of current treatment by a centralized cardiology team to optimize care relative to primary prevention guidelines. During the trial, the centralized cardiology team will monitor the provision of medications prescribed and lab values relative to guidelines, and provide feedback and education to site investigators to support optimization. CCTA results will be centrally archived and will remain blinded to the usual care provider until the end of the study.
Experimental: Cleerly Stage-Based Care
The Cleerly Stage-Based Care group will receive personalized care centrally managed by a remote cardiologist-led team. They will also receive an initial pre-randomization assessment of current treatment by a centralized cardiology team to optimize care relative to primary prevention guidelines. Cleerly CAD Staging System results will be discussed with participants and serve as the basis for standardized algorithm-supported pharmacotherapy \& education, which will be intensified if plaque burden has progressed at 24 months.
Sponsors
Collaborators: CPC Clinical Research
Leads: Cleerly, Inc.

This content was sourced from clinicaltrials.gov