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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cCTA with selective FFRct

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring suspected coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria (all must be present):

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

Exclusion criteria (all must be absent):

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.
a. Resting ECG, resting echocardiogram and resting CMR (MRI) are not exclusionary regardless of when were performed
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

Sites / Locations

Participating site

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Usual Care

Precision evaluation

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Composite of Death / MI / invasive coronary angiography without obstructive disease

All cause death, non-fatal MI or invasive cardiac catheterization without obstructive disease defined as diameter stenosis ≥50%, or with FFR≤0.80, or non- hyperemic pressure ratio (NHPR) <0.90

Secondary Outcome Measures

Full Information

NCT ID

NCT03702244

First Posted

October 3, 2018

Last Updated

September 1, 2022

Sponsor

HeartFlow, Inc.

Collaborators

Duke Clinical Research Institute, Cardiovascular Research Foundation, New York

1. Study Identification

Unique Protocol Identification Number

NCT03702244

Brief Title

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

Acronym

PRECISE

Official Title

Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

November 27, 2018 (Actual)

Primary Completion Date

May 20, 2022 (Actual)

Study Completion Date

May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HeartFlow, Inc.

Collaborators

Duke Clinical Research Institute, Cardiovascular Research Foundation, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

suspected coronary artery disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Arm Title

Precision evaluation

Arm Type

Other

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

cCTA with selective FFRct

Intervention Description

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

Primary Outcome Measure Information:

Title

Composite of Death / MI / invasive coronary angiography without obstructive disease

Description

All cause death, non-fatal MI or invasive cardiac catheterization without obstructive disease defined as diameter stenosis ≥50%, or with FFR≤0.80, or non- hyperemic pressure ratio (NHPR) <0.90

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria (all must be present): 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 Exclusion criteria (all must be absent): 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. a. Resting ECG, resting echocardiogram and resting CMR (MRI) are not exclusionary regardless of when were performed 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela S Douglas

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Participating site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34953768

Citation

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.

Results Reference

derived

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

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