The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization

NCT03702244 | Completed Results DMC FDA Device

• 1 other identifier: CP-907-001-A
• Study Type: interventional
• Target: 2,103
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD, to be performed in outpatient settings, including primary care and cardiology practices.

Conditions

Coronary Artery Disease

Keywords

suspected coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease

  The centrally adjudicated (by Clinical Events Committee) primary end point was a composite of clinical efficiency as a gatekeeper to invasive testing (catheterization without obstructive CAD) and safety (death, non fatal myocardial infarction \[MI\]) at 1 year. Invasive cardiac catheterization without obstructive coronary artery disease defined as the absence of any ≥50% stenosis or hemodynamic indication of significance (no FFR ≤0.80 or iFR≤0.89) in any major epicardial vessel including side branches ≥2 mm in diameter, as determined by core-lab adjudicated quantitative coronary angiography (QCA) or if QCA not performed, by site report. A detailed description and information on the definitions of primary endpoint component definitions is provided in the current version of the study Protocol, Statistical Analysis Plan, and the published trial design article.

  1 year

Secondary Outcomes (5)

• Number of Unplanned Hospitalizations (Including Admissions With Death or MI)

  1 year

• Number of Catheterization and Revascularization Procedures

  1 year

• Number of Participants With Preventive Medication Use

  1 Year

• Number of Participants With Quality of Life (Angina Frequency) Assessment

  1 year

• Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)

  1 year

Study Arms (2)

Usual Care

NO INTERVENTION

For participants randomized to usual care, the participant's care team will select the specific noninvasive stress test (exercise electrocardiogram, stress nuclear imaging \[including PET\], stress MR, or stress echocardiogram); OR invasive test: (direct to diagnostic catheterization).

Precision evaluation

OTHER

Participants randomized to a precision strategy will be assigned to either guideline-recommended care without immediately planned testing (low risk) or cCTA with selective FFRct (elevated risk) using a risk tool based on pretest clinical characteristics derived from the PROMISE trial and validated in SCOT-HEART trial. Participants assigned to guideline-recommended care without planned testing will be treated with preventive and antianginal medical treatment per guideline recommendations and clinical judgment and followed without testing.

Diagnostic Test: cCTA with selective FFRct

Interventions

cCTA with selective FFRct DIAGNOSTIC_TEST

PRECISE will evaluate whether a precision evaluation strategy that combines contemporary risk stratification using the PROMISE Risk Tool with functional and anatomic non-invasive evaluation with cCTA with selective FFRct can improve outcomes over usual care in stable chest pain patients while safely deferring further testing in low-risk patients and reducing cost overall

Precision evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Stable typical or atypical symptoms suggesting possible significant coronary artery disease (CAD) with further non-emergent testing or elective catheterization recommended to evaluate the presence of suspected significant CAD. Stable chest pain (or equivalent) includes those who have fully been ruled out for Acute Coronary Syndrome (ACS) and for whom elective testing is recommended, regardless of the venue in which they are seen.
• If prior CV testing has occurred, it must have been performed greater than one year prior to randomization, and the following must be met:
• cCTA or invasive coronary angiography (ICA) with stenosis \< 50%
• Quantified coronary artery calcium (CAC) \< 100 AG
• Safe performance of cCTA:
• Creatinine clearance ≥45 ml/min per most recent measurement within 90 days
• For a female participant of childbearing potential (those who have not been surgically sterilized or are not postmenopausal), a pregnancy test must be performed with negative results known within 7 days prior to randomization
• Willingness to comply with all aspects of the protocol, including adherence to the assigned strategy and follow-up visits
• Ability to provide written informed consent

You may not qualify if:

• Acute chest pain (in patients who have not been ruled out for ACS)
• Unstable clinical status
• Noninvasive or invasive CV testing for CAD within 1 year. CV testing for CAD refers to any stress tests, invasive coronary angiography (ICA) and cCTA (including calcium scoring) only.
• Lifetime history of known obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%), known EF ≤40% or other moderate to severe valvular or congenital cardiac disease
• Contraindications to cCTA including but not limited to creatinine clearance (GFR) \<45 ml/min as per most recent measurement taken within 90 days
• Exceeds the site's weight or size limit for cCTA or cardiac catheterization
• Any condition leading to possible inability to comply with the protocol procedures or follow-up
• Any condition that might interfere with the study procedures or follow-up
• Enrolled in an investigational trial that involves a non-approved cardiac drug or device which has not reached its primary endpoint
• Life expectancy less than 2 years due to non-cardiovascular comorbidities

Sponsors & Collaborators

• HeartFlow, Inc.: lead
• Duke Clinical Research Institute: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (1)

Participating site

Lake Charles, Louisiana, 70601, United States

Location

Related Publications (5)

• Chew DS, Mark DB, Li Y, Nanna MG, Kelsey MD, Daniels MR, Davidson-Ray L, Baloch KN, Rogers C, Patel MR, Anstrom KJ, Curzen N, Vemulapalli S, Douglas PS; PRECISE Investigators. Economic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011008. doi: 10.1161/CIRCOUTCOMES.123.011008. Epub 2025 Feb 3.

  PMID: 39895495 DERIVED

• Mark DB, Li Y, Nanna MG, Kelsey MD, Daniels MR, Rogers C, Patel MR, Baloch KN, Chow BJW, Anstrom KJ, Vemulapalli S, Weir-McCall JR, Stone GW, Chew DS, Douglas PS; PRECISE Investigators. Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011414. doi: 10.1161/CIRCOUTCOMES.124.011414. Epub 2025 Feb 3.

  PMID: 39895494 DERIVED

• Udelson JE, Kelsey MD, Nanna MG, Fordyce CB, Yow E, Clare RM, Mark DB, Patel MR, Rogers C, Curzen N, Pontone G, Maurovich-Horvat P, De Bruyne B, Greenwood JP, Marinescu V, Leipsic J, Stone GW, Ben-Yehuda O, Berry C, Hogan SE, Redfors B, Ali ZA, Byrne RA, Kramer CM, Yeh RW, Martinez B, Mullen S, Huey W, Anstrom KJ, Al-Khalidi HR, Chiswell K, Vemulapalli S, Douglas PS; PRECISE Investigators. Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease: A Prespecified Secondary Analysis of the PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):915-924. doi: 10.1001/jamacardio.2023.2614.

  PMID: 37610768 DERIVED

• Douglas PS, Nanna MG, Kelsey MD, Yow E, Mark DB, Patel MR, Rogers C, Udelson JE, Fordyce CB, Curzen N, Pontone G, Maurovich-Horvat P, De Bruyne B, Greenwood JP, Marinescu V, Leipsic J, Stone GW, Ben-Yehuda O, Berry C, Hogan SE, Redfors B, Ali ZA, Byrne RA, Kramer CM, Yeh RW, Martinez B, Mullen S, Huey W, Anstrom KJ, Al-Khalidi HR, Vemulapalli S; PRECISE Investigators. Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):904-914. doi: 10.1001/jamacardio.2023.2595.

  PMID: 37610731 DERIVED

• Nanna MG, Vemulapalli S, Fordyce CB, Mark DB, Patel MR, Al-Khalidi HR, Kelsey M, Martinez B, Yow E, Mullen S, Stone GW, Ben-Yehuda O, Udelson JE, Rogers C, Douglas PS. The prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization: Rationale and design of the PRECISE trial. Am Heart J. 2022 Mar;245:136-148. doi: 10.1016/j.ahj.2021.12.004. Epub 2021 Dec 23.

  PMID: 34953768 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Heartflow Inc

whuey@heartflow.com

877-478-3569

Study Officials

• Pamela S Douglas

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who meet all inclusion criteria and none of the exclusion criteria will be randomized in a ratio of 1:1 within a clinical center to either a precision evaluation strategy or usual care using an interactive web or voice-based system (IXRS). Randomization will be stratified by intended first test if randomized to usual care and by classification as minimal vs. elevated risk by the minimal risk model. The randomization scheme within a clinical center will be carried out by the method of random permuted block design with variable block size

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 11, 2018
• Study Start: November 27, 2018
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)