Clinical trial NCT03702244: The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Official title: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: suspected coronary artery disease
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
name: Cardiovascular Research Foundation, New York
First posted: 2018-10-11
Enrollment: 2103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria (all must be present):

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 (all must be absent):

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

Primary outcomes:
measure: Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
timeFrame: 1 year
Secondary outcomes:
measure: Number of Unplanned Hospitalizations (Including Admissions With Death or MI)
timeFrame: 1 year
measure: Number of Catheterization and Revascularization Procedures
timeFrame: 1 year
measure: Number of Participants With Preventive Medication Use
timeFrame: 1 Year
measure: Number of Participants With Quality of Life (Angina Frequency) Assessment
timeFrame: 1 year
measure: Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)
timeFrame: 1 year
Other outcomes:
Locations:
city: Lake Charles
country: United States
facility: Participating site
state: Louisiana
Study officials:
affiliation: Duke University
name: Pamela S Douglas
role: PRINCIPAL_INVESTIGATOR
References:
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.