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

Part of paid clinical trials in Chandler, Arizona.

Sponsor: Cleerly, Inc.
Study ID: NCT06112418
Status: Recruiting

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Conditions

Diabetes Mellitus, Type 2
Metabolic Syndrome
PreDiabetes

Eligibility Criteria

Sex: ALL
Age: 55 Years - N/A
Healthy Volunteers: Accepted

Interventions

The Cleerly CAD Staging System — DEVICE
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.

Study Details

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.

Key Dates

Start date: Mar 6, 2024
Status verified: Jun 2026
Primary completion: Mar 5, 2029
Completion: Mar 5, 2029

Study Design

Enrollment: 7,500 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Arms

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.

Primary Outcome Measure

The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events. [ Time Frame: Through study completion- an average of 3.5 years ]

Central Contacts

Ryann Sardinia
7207398191
[email protected]
Ashley Dunham, PhD
7207398191
[email protected]

Locations (124)

Facility	City	State	ZIP	Site coordinators
Chandler Clinical Trials	Chandler	Arizona	85224	Muhammad Salim, MD
Scottsdale Clinical Trials	Scottsdale	Arizona	85260	Todd Dreitzler, MD
Sun City Research	Sun City	Arizona	85381	Juan Rodriguez, MD
Noble Clinical Research	Tucson	Arizona	85704	Roxana Rodriguez, MD
Amicis Research: Beverly Hills	Beverly Hills	California	90211	Michael Levine, MD
Cardiovascular Research Foundation of Southern California	Beverly Hills	California	90210	Ronald P. Karlsberg, MD
Valiance Clinical Research - Canoga Park	Canoga Park	California	91303	Rami Shaarawy
Cardiovascular Institute of San Diego	Chula Vista	California	91911	Milind D. Parikh, MD
Amicis Research: Granada Hills	Granada Hills	California	91324	Pascal Dabel, MD
Valiance Clinical Research: Huntington Park	Huntington Park	California	90255	Philip Kim, MD
HALO Diagnostics	Indian Wells	California	92210	John F. Feller, MD
Scripps Health	La Jolla	California	92037	Elizabeth Epstein, MD
Chemidox Clinical Trials	Lancaster	California	93534	Pamela Dewar-DeSilva, MD
Loma Linda University Health	Loma Linda	California	92354	Purvi Parwani, MD
Long Beach Research Institute	Long Beach	California	90805	Ashley Duzik, MD
Ace Research Institute - Monterey Park	Monterey Park	California	91754	Yu-Hsiang Sam Lee, MD
Amicis Research: Newhall	Newhall	California	91321	Thuong Vo, MD
Ace Research Institute: Northridge	Northridge	California	91324	Richard Park, MD
Ace Research Institute: Northridge #2	Northridge	California	91325	William Y. Josephson, MD
Amicis Research: Northridge	Northridge	California	91324	Nana Barseghian, MD
Northridge Clinical Trials	Northridge	California	91325	-
University of California- Irvine	Orange	California	92868	Ailin Barseghian El-Farra, MD
Stanford Health Care	Palo Alto	California	94304	Sandra Tsai, MD
VA Palo Alto	Palo Alto	California	94304	Shriram Nallamshetty, MD
Amicis Research: San Fernando	San Fernando	California	91306	Farid Yasharpour, MD
Valiance Clinical Research - Tarzana	Tarzana	California	91356	Harpreet Singh, MD
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center	Torrance	California	90502	Suvasini Lakshmanan, MD
Amicis Research: Valencia	Valencia	California	91355	Dennis Lewis, MD
Concierge Clinical Trials	Valley Village	California	91607	Ruth Espinoza, MD
University of Colorado	Aurora	Colorado	80045	Steve Simon Steve Simon, MD (PRINCIPAL_INVESTIGATOR)
St. Josephs (Intermountain Healthcare)	Denver	Colorado	80218	Christopher Angus, MD
Flourish Medical Research	Boca Raton	Florida	33434	Michael Hafran, MD
Apex Research	Cross City	Florida	32628	Tamir Salmani, MD
Evolution Research Center	Hialeah	Florida	33012	Riquel Gonzalez, MD
UF Health Jacksonville	Jacksonville	Florida	32209	Luis Ortega Paz, MD
Atlantis Clinical Research, LLC	Miami	Florida	33173	Leyvi Alvarado Miranda, MD
Baptist Health Miami Cardiac and Vascular Institute	Miami	Florida	33173	Jonathan Fialkow, MD
BioPhase Research	Miami	Florida	33137	Julie Cadet-Plassman, MD
Farma Medical Inc.	Miami	Florida	33183	Ingrid Fernandez-Milian, MD
Fiel Wellness Clinical Research LLC	Miami	Florida	33135	Osvaldo Caroma, MD
New Access Research and Medical Center	Miami	Florida	33186	Sander Fernandez, MD
United Clinical Research	Miami	Florida	33155	Teresa B. Alfonso, MD Alfonso
Quantum Clinical Trials	Miami Beach	Florida	33140	Christopher A. Fayeghi, MD
Ascension Sacred Heart	Pensacola	Florida	32504	Lauren J. Stipp, MD
Clinical Research Center of Florida	Pompano Beach	Florida	33060	Howard S. Koch, MD
University of South Florida	Tampa	Florida	33620	Shone Almeida, MD
Aiyan Diabetes Center	Augusta	Georgia	30907	Anthony D. Turner, MD
Emory University	Dunwoody	Georgia	30338	Ambar Kulshreshtha, MD
Privia Medical Group Georgia LLC -Fayetteville (Javara)	Fayetteville	Georgia	30214	Charlotte Grayson Mathis, MD
Randomize Now- Atlanta West	Lithia Springs	Georgia	30122	Millard Collier Jr., MD
Randomize Now-Burton Medical	Macon	Georgia	31210	Frederick Burton, MD
Evergreen Clinical Trials	Norcross	Georgia	30092	Dmitriy Pelishev, MD
Peachtree Clinical Solutions - Noir Research Collective	Powder Springs	Georgia	30127	Karan Raghavan, MD
Randomize Now, LLC - Noir Research Collective	Riverdale	Georgia	30296	Claire K. Willie, MD
Privia Medical Group Georgia, LLC (Javara Inc.)	Savannah	Georgia	31406	Thomas G. Moriarity, MD
Privia Medical Group Georgia - Thomasville (Javara)	Thomasville	Georgia	31792	William L. Cooper, MD
Care Institute- High Desert	Meridian	Idaho	83642	David A. Hinchman, MD
Northwestern University	Chicago	Illinois	60611	Paul C. Cremer, MD
Northshore University Health System	Glenview	Illinois	60026	Amit K. Pursnani, MD
Franciscan Physician Network- Indiana Heart Physicians	Indianapolis	Indiana	46237	Ryan P Daly, MD
Indiana Medical Research Institute	Indianapolis	Indiana	46202	Arshad P. Malik
MercyOne Iowa Heart Center	West Des Moines	Iowa	50266	Enrico L. Martin, MD
St Elizabeth Health Care - CRI	Edgewood	Kentucky	41017	Erica Pivato, MD
UofL Health	Louisville	Kentucky	40202	Shahab Ghafghazi, MD
Flourish Bowie dba Flourish Research	Bowie	Maryland	20715	Sara Collins, MD
KUR Research at CMP	Columbia	Maryland	21045	William Saway, MD
Brigham and Women's Hospital	Boston	Massachusetts	02115	Ron Blankstein, MD
Massachusetts General Hospital	Boston	Massachusetts	02114	Pradeep Natarajan, MD
Henry Ford Hospital	Detroit	Michigan	48202	Cori E Russell, MD
Trinity Health Michigan Heart	Ypsilanti	Michigan	48917	Ahmad Mizyed, MD
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	55407	Michael D. Miedema, MD
Saint Louis Heart and Vascular	St Louis	Missouri	63136	Gil Vardi, MD
Washington University School of Medicine	St Louis	Missouri	63110	Farhan M. Katchi, MD
Boeson Research Kalispell	Kalispell	Montana	59901	Justin Buls, MD
Boeson Research Fort Missoula	Missoula	Montana	59804	Audrey Remmers, MD
Bryan Heart	Lincoln	Nebraska	68506	Chad E. Travers, MD
Southwest Medical Associates- Optum Nevada	Las Vegas	Nevada	89102	Tatiana O. Tsvetkova, MD
Vector Clinical Trials	Las Vegas	Nevada	89128	Bharat R. Mocherla, MD
Advanced Heart and Vascular Institute of Hunterdon	Flemington	New Jersey	08822	Andrey Espinoza, MD
Virtua Health, Inc.	Marlton	New Jersey	08053	Mark T. Finch, MD
Rutgers State University	New Brunswick	New Jersey	08901	Sabahat Bokhari, MD
The Valley Hospital	Paramus	New Jersey	07652	Himanshu Gupta, MD
Holy Name Medical Center	Teaneck	New Jersey	07666	Jaffar Raza, MD
Clindove Research	Brooklyn	New York	11221	Nelly Cohen, MD
Swift Clinical Research	Brooklyn	New York	11226	Manoj Dalmia, MD
Rasaj Research	Jackson Heights	New York	11372	Ammara Mushtaq, MD
Optum- Long Island NY	Lake Success	New York	11042	Steven Goldberg, MD
Northwell Health Northern Westchester Hospital	Mount Kisco	New York	10549	Margaret Andersen, MD
Mount Sinai	New York	New York	10029	Solomon Bienstock, MD
Mount Sinai West	New York	New York	10019	Waqas A Malick, MD
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Matthew Cavender, MD
Duke University Hospital	Durham	North Carolina	27701	William Yancy, MD
Durham Veterans Affairs Medical Center (Durham VAMC)	Durham	North Carolina	27705	Hayden Bosworth, MD
Cape Fear Valley Health System (Javara Inc.)	Fayetteville	North Carolina	28304	Nafisa Saleem, MD
West Clinical Research	Morehead City	North Carolina	28557	-
Wake Forest University Health Sciences	Winston-Salem	North Carolina	27157	Michael Shapiro, MD
Sanford Health	Fargo	North Dakota	58102	David J. Clardy, MD
Summa Health	Akron	Ohio	44304	Wissam Alajaji, MD
Hightower Clinical	Oklahoma City	Oklahoma	73007	Faisal Latif, MD
Medical Research International, LLC	Oklahoma City	Oklahoma	73109	Joseph Grillo, MD
Ascension St. John - Jane Phillips Medical Center	Tulsa	Oklahoma	74104	Michael Megaly, MD
Capital Area Research	Camp Hill	Pennsylvania	17011	Venkatesh Nadar, MD
Medical University of South Carolina	Charleston	South Carolina	29425	Marc-Andre Cornier, MD
Community DPC	Cleveland	Tennessee	37312	Carlton Volberg, MD
University of Tennessee Medical Center	Knoxville	Tennessee	37920	Kashif A. Shaikh, MD
TriStar Centennial Medical Center (HCA Health Care)	Nashville	Tennessee	37202	David Huneycutt, MD
Hendrick Health	Abilene	Texas	79601	Ren Zhang, MD
Gadolin Research	Beaumont	Texas	77702	John T Fowler, MD
CardioVoyage, LLC	Greenville	Texas	75402	Marc Demyun, MD
Gulf Coast Clinical Research, LLC	Houston	Texas	77070	Anjani Pandya, MD
Helium Research Group	Houston	Texas	77004	Ijeoma A. Ekeruo
Kelsey Research Foundation	Houston	Texas	77025	Rohan R Wagle, MD
The Methodist Hospital, DeBakey Cardiology Associates	Houston	Texas	77030	Sadeer Al-Kindi, MD
Aeres Clinical Research	Laredo	Texas	78041	Amando Garza, MD
DC Clinical Research	Lewisville	Texas	75057	Moiz M. Shafiq, MD
North Dallas Research Associates - Kerlo Network	McKinney	Texas	75069	Muhammad Akram Khan, MD
SMS Clinical Research	Mesquite	Texas	75149	Salma Saiger, MD
Privia Medical Group Gulf Coast, PLLC ( Javara Inc.)	San Marcos	Texas	78666	Alan Lee, MD
Privia Medical Group- North Texas	Stephenville	Texas	76401	Benjamin Marcum, MD
Kalo Clinical Research	West Valley City	Utah	84120	William J. Walsh, MD
Chippenham Johnston Willis Medical Center	Richmond	Virginia	23225	Michael Arcarese, MD
Providence Regional Medical Center Everett	Everett	Washington	98201	Xiaojing Jennie Shen, MD
University of Washington	Seattle	Washington	98195	Kelley Branch, MD
Charleston Area Medical Center	Charleston	West Virginia	25304	Sarah Rinehart, MD

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