Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
Healthy Volunteers
NCT06112418

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

Led by Cleerly, Inc. · Updated on 2026-04-14

7500

Participants Needed

123

Research Sites

260 weeks

Total Duration

On this page

Sponsors

C

Cleerly, Inc.

Lead Sponsor

C

CPC Clinical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Provided electronic or written informed consent
  • Men older than 55 years, women older than 65 years
  • Have type 2 diabetes requiring medication, prediabetes (HbA1c 5.7 to 6.4% and/or fasting glucose 100-125 mg/dL), or metabolic syndrome defined by at least 3 criteria: BMI ≥ 27 kg/m2 or abnormal waist circumference, fasting triglycerides ≥ 150 mg/dL or treated hypertriglyceridemia, low HDL-cholesterol, high blood pressure or treated hypertension, fasting blood glucose ≥ 100 mg/dL or HbA1c ≥ 5.7%
  • Have a device such as a smartphone, tablet, or computer to communicate with the central cardiologist-led treatment team
Not Eligible

You will not qualify if you...

  • History of symptomatic cardiovascular disease including prior heart attack, unstable angina, stroke, claudication, arterial revascularization, or active cardiologist-managed conditions like atrial fibrillation or heart failure
  • Planned arterial revascularization
  • Unable to complete screening coronary CT angiography or conditions increasing its risk including: low kidney function (eGFR < 60 mL/min/1.73 m2), allergy to iodinated contrast or history of contrast-induced nephropathy, recent thyroid cancer or planned radioactive iodine treatment, weight over 300 lbs (136 kg) or exceeding scanner limits, inability to hold breath over 10 seconds, active arrhythmia with poorly controlled rate, contraindications to beta blocker or nitroglycerin on screening day, or other factors increasing risk or poor scan quality
  • Unsuitable for the trial due to significant left main stenosis, life expectancy less than 3 years, or issues affecting 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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Trial Site Locations

Total: 123 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

Long Beach Research Institute

Long Beach, California, United States, 90805

Actively Recruiting

15

Ace Research Institute - Monterey Park

Monterey Park, California, United States, 91754

Actively Recruiting

16

Amicis Research: Newhall

Newhall, California, United States, 91321

Actively Recruiting

17

Ace Research Institute: Northridge

Northridge, California, United States, 91324

Actively Recruiting

18

Amicis Research: Northridge

Northridge, California, United States, 91324

Actively Recruiting

19

Ace Research Institute: Northridge #2

Northridge, California, United States, 91325

Actively Recruiting

20

Northridge Clinical Trials

Northridge, California, United States, 91325

Actively Recruiting

21

University of California- Irvine

Orange, California, United States, 92868

Actively Recruiting

22

Stanford Health Care

Palo Alto, California, United States, 94304

Actively Recruiting

23

VA Palo Alto

Palo Alto, California, United States, 94304

Actively Recruiting

24

Amicis Research: San Fernando

San Fernando, California, United States, 91306

Actively Recruiting

25

Valiance Clinical Research - Tarzana

Tarzana, California, United States, 91356

Actively Recruiting

26

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

Torrance, California, United States, 90502

Actively Recruiting

27

Amicis Research: Valencia

Valencia, California, United States, 91355

Actively Recruiting

28

Concierge Clinical Trials

Valley Village, California, United States, 91607

Actively Recruiting

29

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

30

St. Josephs (Intermountain Healthcare)

Denver, Colorado, United States, 80218

Actively Recruiting

31

Flourish Medical Research

Boca Raton, Florida, United States, 33434

Actively Recruiting

32

Apex Research

Cross City, Florida, United States, 32628

Actively Recruiting

33

Evolution Research Center

Hialeah, Florida, United States, 33012

Actively Recruiting

34

UF Health Jacksonville

Jacksonville, Florida, United States, 32209

Actively Recruiting

35

Fiel Wellness Clinical Research LLC

Miami, Florida, United States, 33135

Actively Recruiting

36

BioPhase Research

Miami, Florida, United States, 33137

Actively Recruiting

37

United Clinical Research

Miami, Florida, United States, 33155

Actively Recruiting

38

Atlantis Clinical Research, LLC

Miami, Florida, United States, 33173

Actively Recruiting

39

Baptist Health Miami Cardiac and Vascular Institute

Miami, Florida, United States, 33173

Actively Recruiting

40

Farma Medical Inc.

Miami, Florida, United States, 33183

Actively Recruiting

41

New Access Research and Medical Center

Miami, Florida, United States, 33186

Actively Recruiting

42

Quantum Clinical Trials

Miami Beach, Florida, United States, 33140

Actively Recruiting

43

Ascension Sacred Heart

Pensacola, Florida, United States, 32504

Actively Recruiting

44

Clinical Research Center of Florida

Pompano Beach, Florida, United States, 33060

Actively Recruiting

45

University of South Florida

Tampa, Florida, United States, 33620

Actively Recruiting

46

Aiyan Diabetes Center

Augusta, Georgia, United States, 30907

Actively Recruiting

47

Emory University

Dunwoody, Georgia, United States, 30338

Actively Recruiting

48

Privia Medical Group Georgia LLC -Fayetteville (Javara)

Fayetteville, Georgia, United States, 30214

Actively Recruiting

49

Randomize Now- Atlanta West

Lithia Springs, Georgia, United States, 30122

Actively Recruiting

50

Randomize Now-Burton Medical

Macon, Georgia, United States, 31210

Actively Recruiting

51

Evergreen Clinical Trials

Norcross, Georgia, United States, 30092

Actively Recruiting

52

Peachtree Clinical Solutions - Noir Research Collective

Powder Springs, Georgia, United States, 30127

Actively Recruiting

53

Randomize Now, LLC - Noir Research Collective

Riverdale, Georgia, United States, 30296

Actively Recruiting

54

Privia Medical Group Georgia, LLC (Javara Inc.)

Savannah, Georgia, United States, 31406

Actively Recruiting

55

Privia Medical Group Georgia - Thomasville (Javara)

Thomasville, Georgia, United States, 31792

Actively Recruiting

56

Care Institute- High Desert

Meridian, Idaho, United States, 83642

Actively Recruiting

57

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

58

Northshore University Health System

Glenview, Illinois, United States, 60026

Actively Recruiting

59

Indiana Medical Research Institute

Indianapolis, Indiana, United States, 46202

Actively Recruiting

60

Franciscan Physician Network- Indiana Heart Physicians

Indianapolis, Indiana, United States, 46237

Actively Recruiting

61

MercyOne Iowa Heart Center

West Des Moines, Iowa, United States, 50266

Actively Recruiting

62

St Elizabeth Health Care - CRI

Edgewood, Kentucky, United States, 41017

Actively Recruiting

63

UofL Health

Louisville, Kentucky, United States, 40202

Actively Recruiting

64

Flourish Bowie dba Flourish Research

Bowie, Maryland, United States, 20715

Actively Recruiting

65

KUR Research at CMP

Columbia, Maryland, United States, 21045

Actively Recruiting

66

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

67

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

68

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

69

Trinity Health Michigan Heart

Ypsilanti, Michigan, United States, 48917

Actively Recruiting

70

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

71

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

72

Saint Louis Heart and Vascular

St Louis, Missouri, United States, 63136

Actively Recruiting

73

Boeson Research Kalispell

Kalispell, Montana, United States, 59901

Actively Recruiting

74

Boeson Research Fort Missoula

Missoula, Montana, United States, 59804

Actively Recruiting

75

Bryan Heart

Lincoln, Nebraska, United States, 68506

Actively Recruiting

76

Southwest Medical Associates- Optum Nevada

Las Vegas, Nevada, United States, 89102

Actively Recruiting

77

Vector Clinical Trials

Las Vegas, Nevada, United States, 89128

Actively Recruiting

78

Advanced Heart and Vascular Institute of Hunterdon

Flemington, New Jersey, United States, 08822

Actively Recruiting

79

Virtua Health, Inc.

Marlton, New Jersey, United States, 08053

Actively Recruiting

80

Rutgers State University

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

81

The Valley Hospital

Paramus, New Jersey, United States, 07652

Actively Recruiting

82

Holy Name Medical Center

Teaneck, New Jersey, United States, 07666

Actively Recruiting

83

Clindove Research

Brooklyn, New York, United States, 11221

Actively Recruiting

84

Swift Clinical Research

Brooklyn, New York, United States, 11226

Actively Recruiting

85

Rasaj Research

Jackson Heights, New York, United States, 11372

Actively Recruiting

86

Optum- Long Island NY

Lake Success, New York, United States, 11042

Actively Recruiting

87

Northwell Health Northern Westchester Hospital

Mount Kisco, New York, United States, 10549

Actively Recruiting

88

Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

89

Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

90

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

91

Duke University Hospital

Durham, North Carolina, United States, 27701

Actively Recruiting

92

Durham Veterans Affairs Medical Center (Durham VAMC)

Durham, North Carolina, United States, 27705

Actively Recruiting

93

Cape Fear Valley Health System (Javara Inc.)

Fayetteville, North Carolina, United States, 28304

Actively Recruiting

94

West Clinical Research

Morehead City, North Carolina, United States, 28557

Actively Recruiting

95

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

96

Sanford Health

Fargo, North Dakota, United States, 58102

Actively Recruiting

97

Summa Health

Akron, Ohio, United States, 44304

Actively Recruiting

98

Hightower Clinical

Oklahoma City, Oklahoma, United States, 73007

Actively Recruiting

99

Medical Research International, LLC

Oklahoma City, Oklahoma, United States, 73109

Actively Recruiting

100

Ascension St. John - Jane Phillips Medical Center

Tulsa, Oklahoma, United States, 74104

Actively Recruiting

101

Capital Area Research

Camp Hill, Pennsylvania, United States, 17011

Actively Recruiting

102

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

103

Community DPC

Cleveland, Tennessee, United States, 37312

Actively Recruiting

104

University of Tennessee Medical Center

Knoxville, Tennessee, United States, 37920

Actively Recruiting

105

TriStar Centennial Medical Center (HCA Health Care)

Nashville, Tennessee, United States, 37202

Actively Recruiting

106

Hendrick Health

Abilene, Texas, United States, 79601

Actively Recruiting

107

Gadolin Research

Beaumont, Texas, United States, 77702

Actively Recruiting

108

CardioVoyage, LLC

Greenville, Texas, United States, 75402

Actively Recruiting

109

Helium Research Group

Houston, Texas, United States, 77004

Actively Recruiting

110

Kelsey Research Foundation

Houston, Texas, United States, 77025

Actively Recruiting

111

The Methodist Hospital, DeBakey Cardiology Associates

Houston, Texas, United States, 77030

Actively Recruiting

112

Gulf Coast Clinical Research, LLC

Houston, Texas, United States, 77070

Actively Recruiting

113

Aeres Clinical Research

Laredo, Texas, United States, 78041

Actively Recruiting

114

DC Clinical Research

Lewisville, Texas, United States, 75057

Actively Recruiting

115

North Dallas Research Associates - Kerlo Network

McKinney, Texas, United States, 75069

Actively Recruiting

116

SMS Clinical Research

Mesquite, Texas, United States, 75149

Actively Recruiting

117

Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)

San Marcos, Texas, United States, 78666

Actively Recruiting

118

Privia Medical Group- North Texas

Stephenville, Texas, United States, 76401

Actively Recruiting

119

Kalo Clinical Research

West Valley City, Utah, United States, 84120

Not Yet Recruiting

120

Chippenham Johnston Willis Medical Center

Richmond, Virginia, United States, 23225

Actively Recruiting

121

Providence Regional Medical Center Everett

Everett, Washington, United States, 98201

Actively Recruiting

122

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

123

Charleston Area Medical Center

Charleston, West Virginia, United States, 25304

Actively Recruiting

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Research Team

R

Ryann Sardinia

CONTACT

A

Ashley Dunham, PhD

CONTACT

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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