Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association.
Connie W Tsao, Aaron W Aday, Zaid I Almarzooq...
https://pubmed.ncbi.nlm.nih.gov/35078371Actively Recruiting
Phase Not Applicable
Age: 55Years +
All Genders
Healthy Volunteers
ID06112418
A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events
Led by Cleerly, Inc. · Updated on 2026-06-02
7500
Participants Needed
124
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cleerly, Inc.
Lead Sponsor
C
CPC Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new ways to prevent cardiovascular events in people at increased risk of atherosclerotic cardiovascular disease (ASCVD) but who have no known symptoms. This trial compares a care strategy based on the Cleerly Coronary Artery Disease (CAD) Staging System, which uses imaging and personalized treatment plans, against the usual approach that focuses on traditional risk factors like age, diabetes, and hypertension. The goal is to see if this stage-based care can better reduce heart-related problems. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care from their providers, with oversight from a cardiology team to optimize treatments based on established guidelines, while their imaging results remain blinded. The Cleerly stage-based care group receives personalized care managed remotely by a cardiologist team, who use CAD imaging results to guide treatment and education, intensifying therapy if plaque worsens after 24 months. During the study, which lasts about 3.5 years, participants undergo assessments including coronary computed tomography angiography (CCTA) to visualize artery health. Researchers track cardiovascular events and other health outcomes related to heart and kidney function. Medication use and lab results are monitored to support treatment optimization. The study aims to measure if the Cleerly stage-based care reduces cardiovascular events compared to standard risk factor-based care.
CONDITIONS
Brief Title
A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
Who Can Participate
Age: 55Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Provided electronic or written informed consent
- Men over 55 years of age, women over 65 years of age
- Have type 2 diabetes mellitus requiring medication, prediabetes (HbA1c 5.7 to 6.4% or fasting glucose 100-125 mg/dL), or metabolic syndrome defined by at least three specific criteria including high BMI, abnormal waist circumference, high triglycerides, low HDL cholesterol, high blood pressure, or elevated fasting glucose
- Have a device like a smartphone, tablet, or computer to communicate with the central cardiologist-led team
You will not qualify if you...
- History of symptomatic cardiovascular disease such as prior heart attack, angina, stroke, claudication, arterial revascularization, or active management by a cardiologist for conditions like atrial fibrillation or heart failure
- Planned arterial revascularization
- Unable to complete screening coronary computed tomography angiography (CCTA) or conditions increasing risk or reducing scan quality including low kidney function, allergy to contrast dye, recent thyroid cancer, weight over 300 lbs or device limit, inability to hold breath for more than 10 seconds, active uncontrolled arrhythmia, contraindications to beta blockers or nitroglycerin
- Other factors increasing risk or chance of poor scan interpretation as judged by the investigator
- Considered unsuitable by investigator due to significant left main artery stenosis, life expectancy less than 3 years, or issues affecting study compliance such as substance abuse or untreated mental illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Initial assessment and ongoing management over approximately 3.5 years
Participants undergo coronary computed tomography angiography (CCTA) to visualize and quantify coronary artery disease using the Cleerly CAD Staging System. This imaging informs personalized treatment plans for cardiovascular disease prevention.
Initial imaging visit followed by regular remote cardiologist-led management visits
Long-term Monitoring
Duration - Up to an average of 3.5 years
Participants are monitored for cardiovascular events and treatment outcomes over the course of the study, with adjustments to care based on disease progression and risk assessment.
Ongoing remote follow-up visits with cardiology team as needed
Trial Site Locations
Total: 124 locations
1
Chandler Clinical Trials
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
Actively Recruiting
3
Sun City Research
Sun City, Arizona, United States, 85381
Actively Recruiting
4
Noble Clinical Research
Tucson, Arizona, United States, 85704
Actively Recruiting
5
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States, 90210
Actively Recruiting
6
Amicis Research: Beverly Hills
Beverly Hills, California, United States, 90211
Actively Recruiting
7
Valiance Clinical Research - Canoga Park
Canoga Park, California, United States, 91303
Actively Recruiting
8
Cardiovascular Institute of San Diego
Chula Vista, California, United States, 91911
Actively Recruiting
9
Amicis Research: Granada Hills
Granada Hills, California, United States, 91324
Actively Recruiting
10
Valiance Clinical Research: Huntington Park
Huntington Park, California, United States, 90255
Actively Recruiting
11
HALO Diagnostics
Indian Wells, California, United States, 92210
Actively Recruiting
12
Scripps Health
La Jolla, California, United States, 92037
Actively Recruiting
13
Chemidox Clinical Trials
Lancaster, California, United States, 93534
Actively Recruiting
14
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
15
Long Beach Research Institute
Long Beach, California, United States, 90805
Actively Recruiting
16
Ace Research Institute - Monterey Park
Monterey Park, California, United States, 91754
Actively Recruiting
17
Amicis Research: Newhall
Newhall, California, United States, 91321
Actively Recruiting
18
Ace Research Institute: Northridge
Northridge, California, United States, 91324
Actively Recruiting
19
Amicis Research: Northridge
Northridge, California, United States, 91324
Actively Recruiting
20
Ace Research Institute: Northridge #2
Northridge, California, United States, 91325
Actively Recruiting
21
Northridge Clinical Trials
Northridge, California, United States, 91325
Active, Not Recruiting
22
University of California- Irvine
Orange, California, United States, 92868
Actively Recruiting
23
Stanford Health Care
Palo Alto, California, United States, 94304
Actively Recruiting
24
VA Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
25
Amicis Research: San Fernando
San Fernando, California, United States, 91306
Actively Recruiting
26
Valiance Clinical Research - Tarzana
Tarzana, California, United States, 91356
Actively Recruiting
27
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
28
Amicis Research: Valencia
Valencia, California, United States, 91355
Actively Recruiting
29
Concierge Clinical Trials
Valley Village, California, United States, 91607
Actively Recruiting
30
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
31
St. Josephs (Intermountain Healthcare)
Denver, Colorado, United States, 80218
Actively Recruiting
32
Flourish Medical Research
Boca Raton, Florida, United States, 33434
Actively Recruiting
33
Apex Research
Cross City, Florida, United States, 32628
Actively Recruiting
34
Evolution Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
35
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
36
Fiel Wellness Clinical Research LLC
Miami, Florida, United States, 33135
Actively Recruiting
37
BioPhase Research
Miami, Florida, United States, 33137
Actively Recruiting
38
United Clinical Research
Miami, Florida, United States, 33155
Actively Recruiting
39
Atlantis Clinical Research, LLC
Miami, Florida, United States, 33173
Actively Recruiting
40
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, United States, 33173
Actively Recruiting
41
Farma Medical Inc.
Miami, Florida, United States, 33183
Actively Recruiting
42
New Access Research and Medical Center
Miami, Florida, United States, 33186
Actively Recruiting
43
Quantum Clinical Trials
Miami Beach, Florida, United States, 33140
Actively Recruiting
44
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Actively Recruiting
45
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
Actively Recruiting
46
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
47
Aiyan Diabetes Center
Augusta, Georgia, United States, 30907
Actively Recruiting
48
Emory University
Dunwoody, Georgia, United States, 30338
Actively Recruiting
49
Privia Medical Group Georgia LLC -Fayetteville (Javara)
Fayetteville, Georgia, United States, 30214
Actively Recruiting
50
Randomize Now- Atlanta West
Lithia Springs, Georgia, United States, 30122
Actively Recruiting
51
Randomize Now-Burton Medical
Macon, Georgia, United States, 31210
Actively Recruiting
52
Evergreen Clinical Trials
Norcross, Georgia, United States, 30092
Actively Recruiting
53
Peachtree Clinical Solutions - Noir Research Collective
Powder Springs, Georgia, United States, 30127
Actively Recruiting
54
Randomize Now, LLC - Noir Research Collective
Riverdale, Georgia, United States, 30296
Actively Recruiting
55
Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah, Georgia, United States, 31406
Actively Recruiting
56
Privia Medical Group Georgia - Thomasville (Javara)
Thomasville, Georgia, United States, 31792
Actively Recruiting
57
Care Institute- High Desert
Meridian, Idaho, United States, 83642
Actively Recruiting
58
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
59
Northshore University Health System
Glenview, Illinois, United States, 60026
Actively Recruiting
60
Indiana Medical Research Institute
Indianapolis, Indiana, United States, 46202
Actively Recruiting
61
Franciscan Physician Network- Indiana Heart Physicians
Indianapolis, Indiana, United States, 46237
Actively Recruiting
62
MercyOne Iowa Heart Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
63
St Elizabeth Health Care - CRI
Edgewood, Kentucky, United States, 41017
Actively Recruiting
64
UofL Health
Louisville, Kentucky, United States, 40202
Actively Recruiting
65
Flourish Bowie dba Flourish Research
Bowie, Maryland, United States, 20715
Actively Recruiting
66
KUR Research at CMP
Columbia, Maryland, United States, 21045
Actively Recruiting
67
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
68
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
69
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
70
Trinity Health Michigan Heart
Ypsilanti, Michigan, United States, 48917
Actively Recruiting
71
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
72
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
73
Saint Louis Heart and Vascular
St Louis, Missouri, United States, 63136
Actively Recruiting
74
Boeson Research Kalispell
Kalispell, Montana, United States, 59901
Actively Recruiting
75
Boeson Research Fort Missoula
Missoula, Montana, United States, 59804
Actively Recruiting
76
Bryan Heart
Lincoln, Nebraska, United States, 68506
Actively Recruiting
77
Southwest Medical Associates- Optum Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
78
Vector Clinical Trials
Las Vegas, Nevada, United States, 89128
Actively Recruiting
79
Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey, United States, 08822
Actively Recruiting
80
Virtua Health, Inc.
Marlton, New Jersey, United States, 08053
Actively Recruiting
81
Rutgers State University
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
82
The Valley Hospital
Paramus, New Jersey, United States, 07652
Actively Recruiting
83
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Actively Recruiting
84
Clindove Research
Brooklyn, New York, United States, 11221
Actively Recruiting
85
Swift Clinical Research
Brooklyn, New York, United States, 11226
Actively Recruiting
86
Rasaj Research
Jackson Heights, New York, United States, 11372
Actively Recruiting
87
Optum- Long Island NY
Lake Success, New York, United States, 11042
Actively Recruiting
88
Northwell Health Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
Actively Recruiting
89
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
90
Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
91
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
92
Duke University Hospital
Durham, North Carolina, United States, 27701
Actively Recruiting
93
Durham Veterans Affairs Medical Center (Durham VAMC)
Durham, North Carolina, United States, 27705
Actively Recruiting
94
Cape Fear Valley Health System (Javara Inc.)
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
95
West Clinical Research
Morehead City, North Carolina, United States, 28557
Active, Not Recruiting
96
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
97
Sanford Health
Fargo, North Dakota, United States, 58102
Actively Recruiting
98
Summa Health
Akron, Ohio, United States, 44304
Actively Recruiting
99
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73007
Actively Recruiting
100
Medical Research International, LLC
Oklahoma City, Oklahoma, United States, 73109
Actively Recruiting
101
Ascension St. John - Jane Phillips Medical Center
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
102
Capital Area Research
Camp Hill, Pennsylvania, United States, 17011
Actively Recruiting
103
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
104
Community DPC
Cleveland, Tennessee, United States, 37312
Actively Recruiting
105
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
106
TriStar Centennial Medical Center (HCA Health Care)
Nashville, Tennessee, United States, 37202
Actively Recruiting
107
Hendrick Health
Abilene, Texas, United States, 79601
Actively Recruiting
108
Gadolin Research
Beaumont, Texas, United States, 77702
Actively Recruiting
109
CardioVoyage, LLC
Greenville, Texas, United States, 75402
Actively Recruiting
110
Helium Research Group
Houston, Texas, United States, 77004
Actively Recruiting
111
Kelsey Research Foundation
Houston, Texas, United States, 77025
Actively Recruiting
112
The Methodist Hospital, DeBakey Cardiology Associates
Houston, Texas, United States, 77030
Actively Recruiting
113
Gulf Coast Clinical Research, LLC
Houston, Texas, United States, 77070
Actively Recruiting
114
Aeres Clinical Research
Laredo, Texas, United States, 78041
Actively Recruiting
115
DC Clinical Research
Lewisville, Texas, United States, 75057
Actively Recruiting
116
North Dallas Research Associates - Kerlo Network
McKinney, Texas, United States, 75069
Actively Recruiting
117
SMS Clinical Research
Mesquite, Texas, United States, 75149
Actively Recruiting
118
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
San Marcos, Texas, United States, 78666
Actively Recruiting
119
Privia Medical Group- North Texas
Stephenville, Texas, United States, 76401
Actively Recruiting
120
Kalo Clinical Research
West Valley City, Utah, United States, 84120
Not Yet Recruiting
121
Chippenham Johnston Willis Medical Center
Richmond, Virginia, United States, 23225
Actively Recruiting
122
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Actively Recruiting
123
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
124
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
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Research Team
R
Ryann Sardinia
A
Ashley Dunham, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Non-invasive screening for coronary artery disease in asymptomatic diabetic patients: a systematic review and meta-analysis of randomised controlled trials.
Olivier F Clerc, Tobias A Fuchs, Julia Stehli...
https://pubmed.ncbi.nlm.nih.gov/29452348