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Purpose

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

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Provided electronic or written informed consent 2. Men > 55, women > 65 years of age 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): - 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% 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

Exclusion Criteria

  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. Planned arterial revascularization 3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including: 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) 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. 3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment 4. Weight > 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site 5. Inability to hold breath for > 10 seconds 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) 7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA 8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Prospective, randomized, open blinded endpoint (PROBE), event-driven pragmatic trial
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: The Cleerly CAD Staging System
    The Cleerly CAD Staging System is software that utilizes a proprietary algorithm to identify CAD, stage the severity of CAD when present, and generate a prognostic risk score to inform treatment decisions that support CV disease prevention.

Recruiting Locations

Chandler Clinical Trials
Chandler, Arizona 85224
Contact:
Muhammad Salim, MD

Scottsdale Clinical Trials
Scottsdale, Arizona 85260
Contact:
Todd Dreitzler, MD

Sun City Research
Sun City, Arizona 85381
Contact:
Juan Rodriguez, MD

Noble Clinical Research
Tucson, Arizona 85704
Contact:
Roxana Rodriguez, MD

Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210
Contact:
Ronald P. Karlsberg, MD

Amicis Research: Beverly Hills
Beverly Hills, California 90211
Contact:
Michael Levine, MD

Valiance Clinical Research - Canoga Park
Canoga Park, California 91303
Contact:
Rami Shaarawy

Cardiovascular Institute of San Diego
Chula Vista, California 91911
Contact:
Milind D. Parikh, MD

Amicis Research: Granada Hills
Granada Hills, California 91324
Contact:
Pascal Dabel, MD

Valiance Clinical Research: Huntington Park
Huntington Park, California 90255
Contact:
Philip Kim, MD

HALO Diagnostics
Indian Wells, California 92210
Contact:
John F. Feller, MD

Scripps Health
La Jolla, California 92037
Contact:
Elizabeth Epstein, MD

Chemidox Clinical Trials
Lancaster, California 93534
Contact:
Pamela Dewar-DeSilva, MD

Loma Linda University Health
Loma Linda, California 92354
Contact:
Purvi Parwani, MD

Long Beach Research Institute
Long Beach, California 90805
Contact:
Ashley Duzik, MD

Ace Research Institute - Monterey Park
Monterey Park, California 91754
Contact:
Yu-Hsiang Sam Lee, MD

Amicis Research: Newhall
Newhall, California 91321
Contact:
Thuong Vo, MD

Ace Research Institute: Northridge
Northridge, California 91324
Contact:
Richard Park, MD

Amicis Research: Northridge
Northridge, California 91324
Contact:
Nana Barseghian, MD

Ace Research Institute: Northridge #2
Northridge, California 91325
Contact:
William Y. Josephson, MD

University of California- Irvine
Orange, California 92868
Contact:
Ailin Barseghian El-Farra, MD

Stanford Health Care
Palo Alto, California 94304
Contact:
Sandra Tsai, MD

VA Palo Alto
Palo Alto, California 94304
Contact:
Shriram Nallamshetty, MD

Amicis Research: San Fernando
San Fernando, California 91306
Contact:
Farid Yasharpour, MD

Valiance Clinical Research - Tarzana
Tarzana, California 91356
Contact:
Harpreet Singh, MD

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California 90502
Contact:
Suvasini Lakshmanan, MD

Amicis Research: Valencia
Valencia, California 91355
Contact:
Dennis Lewis, MD

Concierge Clinical Trials
Valley Village, California 91607
Contact:
Ruth Espinoza, MD

University of Colorado
Aurora, Colorado 80045
Contact:
Steve Simon

St. Josephs (Intermountain Healthcare)
Denver, Colorado 80218
Contact:
Christopher Angus, MD

Flourish Medical Research
Boca Raton, Florida 33434
Contact:
Michael Hafran, MD

Apex Research
Cross City, Florida 32628
Contact:
Tamir Salmani, MD

Evolution Research Center
Hialeah, Florida 33012
Contact:
Riquel Gonzalez, MD

UF Health Jacksonville
Jacksonville, Florida 32209
Contact:
Luis Ortega Paz, MD

Fiel Wellness Clinical Research LLC
Miami, Florida 33135
Contact:
Osvaldo Caroma, MD

BioPhase Research
Miami, Florida 33137
Contact:
Julie Cadet-Plassman, MD

United Clinical Research
Miami, Florida 33155
Contact:
Teresa B. Alfonso, MD

Atlantis Clinical Research, LLC
Miami, Florida 33173
Contact:
Leyvi Alvarado Miranda, MD

Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida 33173
Contact:
Jonathan Fialkow, MD

Farma Medical Inc.
Miami, Florida 33183
Contact:
Ingrid Fernandez-Milian, MD

New Access Research and Medical Center
Miami, Florida 33186
Contact:
Sander Fernandez, MD

Quantum Clinical Trials
Miami Beach, Florida 33140
Contact:
Christopher A. Fayeghi, MD

Ascension Sacred Heart
Pensacola, Florida 32504
Contact:
Lauren J. Stipp, MD

Clinical Research Center of Florida
Pompano Beach, Florida 33060
Contact:
Howard S. Koch, MD

University of South Florida
Tampa, Florida 33620
Contact:
Shone Almeida, MD

Aiyan Diabetes Center
Augusta, Georgia 30907
Contact:
Anthony D. Turner, MD

Emory University
Dunwoody, Georgia 30338
Contact:
Ambar Kulshreshtha, MD

Privia Medical Group Georgia LLC -Fayetteville (Javara)
Fayetteville, Georgia 30214
Contact:
Charlotte Grayson Mathis, MD

Randomize Now- Atlanta West
Lithia Springs, Georgia 30122
Contact:
Millard Collier Jr., MD

Randomize Now-Burton Medical
Macon, Georgia 31210
Contact:
Frederick Burton, MD

Evergreen Clinical Trials
Norcross, Georgia 30092
Contact:
Dmitriy Pelishev, MD

Peachtree Clinical Solutions - Noir Research Collective
Powder Springs, Georgia 30127
Contact:
Karan Raghavan, MD

Randomize Now, LLC - Noir Research Collective
Riverdale, Georgia 30296
Contact:
Claire K. Willie, MD

Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah, Georgia 31406
Contact:
Thomas G. Moriarity, MD

Privia Medical Group Georgia - Thomasville (Javara)
Thomasville, Georgia 31792
Contact:
William L. Cooper, MD

Care Institute- High Desert
Meridian, Idaho 83642
Contact:
David A. Hinchman, MD

Northwestern University
Chicago, Illinois 60611
Contact:
Paul C. Cremer, MD

Northshore University Health System
Glenview, Illinois 60026
Contact:
Amit K. Pursnani, MD

Indiana Medical Research Institute
Indianapolis, Indiana 46202
Contact:
Arshad P. Malik

Franciscan Physician Network- Indiana Heart Physicians
Indianapolis, Indiana 46237
Contact:
Ryan P Daly, MD

MercyOne Iowa Heart Center
West Des Moines, Iowa 50266
Contact:
Enrico L. Martin, MD

St Elizabeth Health Care - CRI
Edgewood, Kentucky 41017
Contact:
Erica Pivato, MD

UofL Health
Louisville, Kentucky 40202
Contact:
Shahab Ghafghazi, MD

Flourish Bowie dba Flourish Research
Bowie, Maryland 20715
Contact:
Sara Collins, MD

KUR Research at CMP
Columbia, Maryland 21045
Contact:
William Saway, MD

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Pradeep Natarajan, MD

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Ron Blankstein, MD

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Cori E Russell, MD

Trinity Health Michigan Heart
Ypsilanti, Michigan 48917
Contact:
Ahmad Mizyed, MD

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
Contact:
Michael D. Miedema, MD

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Farhan M. Katchi, MD

Saint Louis Heart and Vascular
St Louis, Missouri 63136
Contact:
Gil Vardi, MD

Boeson Research Kalispell
Kalispell, Montana 59901
Contact:
Justin Buls, MD

Boeson Research Fort Missoula
Missoula, Montana 59804
Contact:
Audrey Remmers, MD

Bryan Heart
Lincoln, Nebraska 68506
Contact:
Chad E. Travers, MD

Southwest Medical Associates- Optum Nevada
Las Vegas, Nevada 89102
Contact:
Tatiana O. Tsvetkova, MD

Vector Clinical Trials
Las Vegas, Nevada 89128
Contact:
Bharat R. Mocherla, MD

Advanced Heart and Vascular Institute of Hunterdon
Flemington, New Jersey 08822
Contact:
Andrey Espinoza, MD

Virtua Health, Inc.
Marlton, New Jersey 08053
Contact:
Mark T. Finch, MD

Rutgers State University
New Brunswick, New Jersey 08901
Contact:
Sabahat Bokhari, MD

The Valley Hospital
Paramus, New Jersey 07652
Contact:
Himanshu Gupta, MD

Holy Name Medical Center
Teaneck, New Jersey 07666
Contact:
Jaffar Raza, MD

Clindove Research
Brooklyn, New York 11221
Contact:
Nelly Cohen, MD

Swift Clinical Research
Brooklyn, New York 11226
Contact:
Manoj Dalmia, MD

Rasaj Research
Jackson Heights, New York 11372
Contact:
Ammara Mushtaq, MD

Optum- Long Island NY
Lake Success, New York 11042
Contact:
Steven Goldberg, MD

Northwell Health Northern Westchester Hospital
Mount Kisco, New York 10549
Contact:
Margaret Andersen, MD

Mount Sinai West
New York, New York 10019
Contact:
Waqas A Malick, MD

Mount Sinai
New York, New York 10029
Contact:
Solomon Bienstock, MD

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Matthew Cavender, MD

Duke University Hospital
Durham, North Carolina 27701
Contact:
William Yancy, MD

Durham Veterans Affairs Medical Center (Durham VAMC)
Durham, North Carolina 27705
Contact:
Hayden Bosworth, MD

Cape Fear Valley Health System (Javara Inc.)
Fayetteville, North Carolina 28304
Contact:
Nafisa Saleem, MD

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Michael Shapiro, MD

Sanford Health
Fargo, North Dakota 58102
Contact:
David J. Clardy, MD

Summa Health
Akron, Ohio 44304
Contact:
Wissam Alajaji, MD

Hightower Clinical
Oklahoma City, Oklahoma 73007
Contact:
Faisal Latif, MD

Medical Research International, LLC
Oklahoma City, Oklahoma 73109
Contact:
Joseph Grillo, MD

Ascension St. John - Jane Phillips Medical Center
Tulsa, Oklahoma 74104
Contact:
Michael Megaly, MD

Capital Area Research
Camp Hill, Pennsylvania 17011
Contact:
Venkatesh Nadar, MD

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Marc-Andre Cornier, MD

Community DPC
Cleveland, Tennessee 37312
Contact:
Carlton Volberg, MD

University of Tennessee Medical Center
Knoxville, Tennessee 37920
Contact:
Kashif A. Shaikh, MD

TriStar Centennial Medical Center (HCA Health Care)
Nashville, Tennessee 37202
Contact:
David Huneycutt, MD

Hendrick Health
Abilene, Texas 79601
Contact:
Ren Zhang, MD

Gadolin Research
Beaumont, Texas 77702
Contact:
John T Fowler, MD

CardioVoyage, LLC
Greenville, Texas 75402
Contact:
Marc Demyun, MD

Helium Research Group
Houston, Texas 77004
Contact:
Ijeoma A. Ekeruo

Kelsey Research Foundation
Houston, Texas 77025
Contact:
Rohan R Wagle, MD

The Methodist Hospital, DeBakey Cardiology Associates
Houston, Texas 77030
Contact:
Sadeer Al-Kindi, MD

Gulf Coast Clinical Research, LLC
Houston, Texas 77070
Contact:
Anjani Pandya, MD

Aeres Clinical Research
Laredo, Texas 78041
Contact:
Amando Garza, MD

DC Clinical Research
Lewisville, Texas 75057
Contact:
Moiz M. Shafiq, MD

North Dallas Research Associates - Kerlo Network
McKinney, Texas 75069
Contact:
Muhammad Akram Khan, MD

SMS Clinical Research
Mesquite, Texas 75149
Contact:
Salma Saiger, MD

Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
San Marcos, Texas 78666
Contact:
Alan Lee, MD

Privia Medical Group- North Texas
Stephenville, Texas 76401
Contact:
Benjamin Marcum, MD

Chippenham Johnston Willis Medical Center
Richmond, Virginia 23225
Contact:
Michael Arcarese, MD

Providence Regional Medical Center Everett
Everett, Washington 98201
Contact:
Xiaojing Jennie Shen, MD

University of Washington
Seattle, Washington 98195
Contact:
Kelley Branch, MD

Charleston Area Medical Center
Charleston, West Virginia 25304
Contact:
Sarah Rinehart, MD

More Details

Status
Recruiting
Sponsor
Cleerly, Inc.

Study Contact

Ryann Sardinia
7207398191
ryann.sardinia@cleerlyhealth.com

Detailed Description

Cardiovascular disease (CVD) persists as the leading cause of morbidity and mortality worldwide at high societal cost. The current primary CVD prevention strategy relies upon risk stratification using population health markers such as age, sex, diabetes, hypertension, dyslipidemia and tobacco use, with preventive therapy intensified in higher risk strata. Since these risk factors are indirect surrogate markers of the underlying disease, atherosclerosis, this strategy leads to treatment of individuals with risk factors who do not have atherosclerosis and failure to treat those with significant atherosclerosis who lack risk factors. The current strategy also cannot determine which individuals are inadequately treated despite effective risk factor management (residual risk). With the current approach, the CV death rate is trending upward in the US despite evidence that screening asymptomatic patients reduces CV events and the widespread availability of effective preventive therapies. This randomized, controlled, pragmatic trial is designed to address the unmet need for better strategies to identify asymptomatic individuals at increased risk for CV events due to atherosclerosis and to personalize their treatment based on CV risk estimates using coronary artery disease (CAD) visualization and quantification. This study enrolls patients without known symptoms of ASCVD but who are at increased risk for ASCVD due to their age and having diabetes, prediabetes or metabolic syndrome and tests the hypothesis that a CAD Staging System-based care strategy reduces CV events compared with risk factor-based care. The Cleerly CAD Staging System incorporates imaging-based evaluation for coronary atherosclerosis, algorithm-supported pharmacotherapy and personalized education about their CAD.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.