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

NCT ID: NCT03702244

Last Updated: 2023-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2022-05-20

Brief Summary

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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.

Detailed Description

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Objective was to test a modified initial cCTA strategy (PS) designed to improve clinical efficiency vs usual testing (UT). Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy PS or UT. PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.

Conditions

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Coronary Artery Disease

Keywords

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suspected coronary artery disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual Care

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Precision evaluation

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.

Group Type OTHER

cCTA with selective FFRct

Intervention Type 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

Interventions

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cCTA with selective FFRct

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. 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.
3. If prior CV testing has occurred, it must have been performed greater than one year prior to randomization, and the following must be met:

1. cCTA or invasive coronary angiography (ICA) with stenosis \< 50%
2. Quantified coronary artery calcium (CAC) \< 100 AG
4. Safe performance of cCTA:

1. Creatinine clearance ≥45 ml/min per most recent measurement within 90 days
2. 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
5. Willingness to comply with all aspects of the protocol, including adherence to the assigned strategy and follow-up visits
6. Ability to provide written informed consent

Exclusion Criteria

1. Acute chest pain (in patients who have not been ruled out for ACS)
2. Unstable clinical status
3. 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.

a. Resting ECG, resting echocardiogram and resting CMR (MRI) are not exclusionary regardless of when were performed
4. 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
5. Contraindications to cCTA including but not limited to creatinine clearance (GFR) \<45 ml/min as per most recent measurement taken within 90 days
6. Exceeds the site's weight or size limit for cCTA or cardiac catheterization
7. Any condition leading to possible inability to comply with the protocol procedures or follow-up
8. Any condition that might interfere with the study procedures or follow-up
9. Enrolled in an investigational trial that involves a non-approved cardiac drug or device which has not reached its primary endpoint
10. Life expectancy less than 2 years due to non-cardiovascular comorbidities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Clinical Research Institute

OTHER

Sponsor Role collaborator

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role collaborator

HeartFlow, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela S Douglas

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Participating site

Lake Charles, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39895495 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39895494 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37610768 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37610731 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34953768 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CP-907-001-A

Identifier Type: -

Identifier Source: org_study_id