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

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

  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Metabolic Syndrome

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 5289282, Arizona 5551752 85224
Contact:
Muhammad Salim, MD

Scottsdale Clinical Trials
Scottsdale 5313457, Arizona 5551752 85260
Contact:
Todd Dreitzler, MD

Sun City Research
Sun City 5316201, Arizona 5551752 85381
Contact:
Juan Rodriguez, MD

Noble Clinical Research
Tucson 5318313, Arizona 5551752 85704
Contact:
Dena Petersen, MD

Cardiovascular Research Foundation of Southern California
Beverly Hills 5328041, California 5332921 90210
Contact:
Ronald P. Karlsberg, MD

Amicis Research: Beverly Hills
Beverly Hills 5328041, California 5332921 90211
Contact:
Michael Levine, MD

Valiance Clinical Research - Canoga Park
Canoga Park 5333913, California 5332921 91303
Contact:
Rami Shaarawy

Cardiovascular Institute of San Diego
Chula Vista 5336899, California 5332921 91911
Contact:
Milind D. Parikh, MD

Amicis Research: Granada Hills
Granada Hills 5353433, California 5332921 91324
Contact:
Pascal Dabel, MD

Valiance Clinical Research: Huntington Park
Huntington Park 5358736, California 5332921 90255
Contact:
Philip Kim, MD

HALO Diagnostics
Indian Wells 5359426, California 5332921 92210
Contact:
John F. Feller, MD

Chemidox Clinical Trials
Lancaster 5364940, California 5332921 93534
Contact:
Pamela Dewar-DeSilva, MD

Long Beach Research Institute
Long Beach 5367929, California 5332921 90805
Contact:
Ashley Duzik, MD

Ace Research Institute - Monterey Park
Monterey Park 5374406, California 5332921 91754
Contact:
Yu-Hsiang Sam Lee, MD

Amicis Research: Newhall
Newhall 5376850, California 5332921 91321
Contact:
Thuong Vo, MD

Ace Research Institute: Northridge
Northridge 5377985, California 5332921 91324
Contact:
Richard Park, MD

Amicis Research: Northridge
Northridge 5377985, California 5332921 91324
Contact:
Nana Barseghian, MD

Ace Research Institute: Northridge #2
Northridge 5377985, California 5332921 91325
Contact:
William Y. Josephson, MD

Northridge Clinical Trials
Northridge 5377985, California 5332921 91325
Contact:
Sabreen S. Faqihi, MD

Stanford Health Care
Palo Alto 5380748, California 5332921 94304
Contact:
Sandra Tsai, MD

VA Palo Alto
Palo Alto 5380748, California 5332921 94304
Contact:
Shriram Nallamshetty, MD

Amicis Research: San Fernando
San Fernando 5391945, California 5332921 91306
Contact:
Farid Yasharpour, MD

Valiance Clinical Research - Tarzana
Tarzana 5401143, California 5332921 91356
Contact:
Harpreet Singh, MD

Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance 5403022, California 5332921 90502
Contact:
Suvasini Lakshmanan, MD

Amicis Research: Valencia
Valencia 5405288, California 5332921 91355
Contact:
Dennis Lewis, MD

University of Colorado
Aurora 5412347, Colorado 5417618 80045
Contact:
Steve Simon

St. Josephs (Intermountain Healthcare)
Denver 5419384, Colorado 5417618 80218
Contact:
Christopher Angus, MD

Flourish Medical Research
Boca Raton 4148411, Florida 4155751 33434
Contact:
David Funt, MD

Apex Research
Cross City 4152395, Florida 4155751 32628
Contact:
Tamir Salmani, MD

Evolution Research Center
Hialeah 4158476, Florida 4155751 33012
Contact:
Riquel Gonzalez, MD

UF Health Jacksonville
Jacksonville 4160021, Florida 4155751 32209
Contact:
Luis Ortega Paz, MD

Fiel Wellness Clinical Research LLC
Miami 4164138, Florida 4155751 33135
Contact:
Osvaldo Caroma, MD

BioPhase Research
Miami 4164138, Florida 4155751 33137
Contact:
Julie Cadet-Plassman, MD

United Clinical Research
Miami 4164138, Florida 4155751 33155
Contact:
Teresa B. Alfonso, MD

Atlantis Clinical Research, LLC
Miami 4164138, Florida 4155751 33173
Contact:
Leyvi Alvarado Miranda, MD

Baptist Health Miami Cardiac and Vascular Institute
Miami 4164138, Florida 4155751 33173
Contact:
Jonathan Fialkow, MD

Farma Medical Inc.
Miami 4164138, Florida 4155751 33183
Contact:
Alba Obourke, MD

New Access Research and Medical Center
Miami 4164138, Florida 4155751 33186
Contact:
Sander Fernandez, MD

Quantum Clinical Trials
Miami Beach 4164143, Florida 4155751 33140
Contact:
Christopher A. Fayeghi, MD

Ascension Sacred Heart
Pensacola 4168228, Florida 4155751 32504
Contact:
Lauren J. Stipp, MD

Clinical Research Center of Florida
Pompano Beach 4169014, Florida 4155751 33060
Contact:
Howard S. Koch, MD

University of South Florida
Tampa 4174757, Florida 4155751 33620
Contact:
Shone Almeida, MD

Aiyan Diabetes Center
Augusta 4180531, Georgia 4197000 30907
Contact:
Alain Domkam, MD

Emory University
Dunwoody 4192375, Georgia 4197000 30338
Contact:
Ambar Kulshreshtha, MD

Peachtree Clinical Solutions - Noir Research Collective
Powder Springs 4217214, Georgia 4197000 30127
Contact:
Karan Raghavan, MD

Randomize Now, LLC - Noir Research Collective
Riverdale 4219001, Georgia 4197000 30296
Contact:
Claire K. Willie, MD

Privia Medical Group Georgia, LLC (Javara Inc.)
Savannah 4221552, Georgia 4197000 31406
Contact:
Thomas G. Moriarity, MD

Privia Medical Group Georgia - Thomasville (Javara)
Thomasville 4226348, Georgia 4197000 31792
Contact:
William L. Cooper, MD

Care Institute- High Desert
Meridian 5600685, Idaho 5596512 83642
Contact:
David A. Hinchman, MD

Northshore University Health System
Evanston 4891382, Illinois 4896861 60201
Contact:
Amit K. Pursnani, MD

Indiana Medical Research Institute
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Arshad P. Malik

Franciscan Physician Network- Indiana Heart Physicians
Indianapolis 4259418, Indiana 4921868 46237
Contact:
Ryan P Daly, MD

MercyOne Iowa Heart Center
West Des Moines 4881346, Iowa 4862182 50266
Contact:
Enrico L. Martin, MD

St Elizabeth Health Care - CRI
Edgewood 4290873, Kentucky 6254925 41017
Contact:
Erica Pivato, MD

UofL Health
Louisville 4299276, Kentucky 6254925 40202
Contact:
Shahab Ghafghazi, MD

Flourish Bowie dba Flourish Research
Bowie 4349159, Maryland 4361885 20715
Contact:
Sara Collins, MD

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Pradeep Natarajan, MD

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Ron Blankstein, MD

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Contact:
Cori E Russell, MD

Trinity Health Michigan Heart
Ypsilanti 5015688, Michigan 5001836 48917
Contact:
Ahmad Mizyed, MD

Minneapolis Heart Institute Foundation
Minneapolis 5037649, Minnesota 5037779 55407
Contact:
Michael D. Miedema, MD

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Farhan M. Katchi, MD

Saint Louis Heart and Vascular
St Louis 4407066, Missouri 4398678 63136
Contact:
Gil Vardi, MD

Boeson Research Kalispell
Kalispell 5660340, Montana 5667009 59901
Contact:
Justin Buls, MD

Boeson Research Fort Missoula
Missoula 5666639, Montana 5667009 59804
Contact:
Audrey Remmers, MD

Bryan Heart
Lincoln 5072006, Nebraska 5073708 68506
Contact:
Natraj Katta, MD

Southwest Medical Associates- Optum Nevada
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Tatiana O. Tsvetkova, MD

Vector Clinical Trials
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Bharat R. Mocherla, MD

Advanced Heart and Vascular Institute of Hunterdon
Flemington 5098124, New Jersey 5101760 08822
Contact:
Andrey Espinoza, MD

Virtua Health, Inc.
Marlton 4502911, New Jersey 5101760 08053
Contact:
Mark T. Finch, MD

Rutgers State University
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Sabahat Bokhari, MD

The Valley Hospital
Paramus 5102387, New Jersey 5101760 07652
Contact:
Himanshu Gupta, MD

Holy Name Medical Center
Teaneck 5105262, New Jersey 5101760 07666
Contact:
Jaffar Raza, MD

Clindove Research
Brooklyn 5110302, New York 5128638 11221
Contact:
Nelly Cohen, MD

Swift Clinical Research
Brooklyn 5110302, New York 5128638 11226
Contact:
Manoj Dalmia, MD

Rasaj Research
Jackson Heights 5122477, New York 5128638 11372
Contact:
Ammara Mushtaq, MD

Optum- Long Island NY
Lake Success 5123853, New York 5128638 11042
Contact:
Steven Goldberg, MD

Northwell Health Northern Westchester Hospital
Mount Kisco 5127744, New York 5128638 10549
Contact:
Margaret Andersen, MD

Mount Sinai West
New York 5128581, New York 5128638 10019
Contact:
Waqas A Malick, MD

Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Solomon Bienstock, MD

University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Matthew Cavender, MD

Duke University Hospital
Durham 4464368, North Carolina 4482348 27701
Contact:
William Yancy, MD

Cape Fear Valley Health System (Javara Inc.)
Fayetteville 4466033, North Carolina 4482348 28304
Contact:
Nafisa Saleem, MD

West Clinical Research
Morehead City 4480153, North Carolina 4482348 28557
Contact:
Patrick J. Morgante, MD

Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Michael Shapiro, MD

Sanford Health
Fargo 5059163, North Dakota 5690763 58102
Contact:
David J. Clardy, MD

Summa Health
Akron 5145476, Ohio 5165418 44304
Contact:
Wissam Alajaji, MD

Hightower Clinical
Oklahoma City 4544349, Oklahoma 4544379 73007
Contact:
Faisal Latif, MD

Medical Research International, LLC
Oklahoma City 4544349, Oklahoma 4544379 73109
Contact:
Joseph Grillo, MD

Ascension St. John - Jane Phillips Medical Center
Tulsa 4553433, Oklahoma 4544379 74104
Contact:
Michael Megaly, MD

Capital Area Research
Camp Hill 5182928, Pennsylvania 6254927 17011
Contact:
Venkatesh Nadar, MD

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Marc-Andre Cornier, MD

Community DPC
Cleveland 4614088, Tennessee 4662168 37312
Contact:
Carlton Volberg, MD

University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920
Contact:
Kashif A. Shaikh, MD

TriStar Centennial Medical Center (HCA Health Care)
Nashville 4644585, Tennessee 4662168 37202
Contact:
David Huneycutt, MD

Hendrick Health
Abilene 4669635, Texas 4736286 79601
Contact:
Ren Zhang, MD

Gadolin Research
Beaumont 4672989, Texas 4736286 77702
Contact:
John T Fowler, MD

CardioVoyage, LLC
Greenville 4695066, Texas 4736286 75402
Contact:
Marc Demyun, MD

Helium Research Group
Houston 4699066, Texas 4736286 77004
Contact:
Ijeoma A. Ekeruo

Kelsey Research Foundation
Houston 4699066, Texas 4736286 77025
Contact:
Rohan R Wagle, MD

The Methodist Hospital, DeBakey Cardiology Associates
Houston 4699066, Texas 4736286 77030
Contact:
Sadeer Al-Kindi, MD

Gulf Coast Clinical Research, LLC
Houston 4699066, Texas 4736286 77070
Contact:
Anjani Pandya, MD

Aeres Clinical Research
Laredo 4705349, Texas 4736286 78041
Contact:
Amando Garza, MD

DC Clinical Research
Lewisville 4706057, Texas 4736286 75057
Contact:
Moiz M. Shafiq, MD

North Dallas Research Associates - Kerlo Network
McKinney 4710178, Texas 4736286 75069
Contact:
Muhammad Akram Khan, MD

SMS Clinical Research
Mesquite 4710826, Texas 4736286 75149
Contact:
Salma Saiger, MD

Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)
San Marcos 4726491, Texas 4736286 78666
Contact:
Alan Lee, MD

Privia Medical Group- North Texas
Stephenville 4734350, Texas 4736286 76401
Contact:
Benjamin Marcum, MD

Chippenham Johnston Willis Medical Center
Richmond 4781708, Virginia 6254928 23225
Contact:
Michael Arcarese, MD

Charleston Area Medical Center
Charleston 4801859, West Virginia 4826850 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.