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

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ClinicalTrials.gov Identifier: NCT03702244
Recruitment Status : Completed
First Posted : October 11, 2018
Results First Posted : December 29, 2023
Last Update Posted : December 29, 2023
Sponsor:
Collaborators:
Duke Clinical Research Institute
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
HeartFlow, Inc.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diagnostic Test: cCTA with selective FFRct Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Actual Study Start Date : November 27, 2018
Actual Primary Completion Date : May 20, 2022
Actual Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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).
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.
Diagnostic Test: 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




Primary Outcome Measures :
  1. Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Number of Unplanned Hospitalizations (Including Admissions With Death or MI) [ Time Frame: 1 year ]
    Urgent and unscheduled hospitalizations for cardiovascular causes include hospitalization for ischemic heart disease including myocardial infarction and unstable angina, cerebrovascular disease including stroke and TIA, heart failure, acute and/or critical limb ischemia, other thrombotic events including pulmonary embolism, arrhythmias, cardiac arrest and other clear cardiovascular causes for hospitalization that do not meet the criteria for the specific events listed here (e.g., hospitalization for acute cardiac chest pain that does not meet the criteria for MI or UA).

  2. Number of Catheterization and Revascularization Procedures [ Time Frame: 1 year ]
    Catheterization efficiency was defined as the proportion of invasive cardiac catheterization patients who undergo revascularization (PCI or CABG) within 6 months. Revascularization may occur either percutaneously (PCI) or surgically (CABG) or as hybrid (PCI and CABG). For PCI, any intervention on a lesion in the coronary tree (including angioplasty, stenting, intravascular lithotripsy) whether successful or not will be considered a revascularization. For CABG the start of the surgical procedure (skin incision) was considered as CABG, whether the procedure was successful or not. Staged revascularization was considered as one revascularization event.

  3. Number of Participants With Preventive Medication Use [ Time Frame: 1 Year ]
    Lipid-lowering agents included statins, ezetimibe, PCSK9 inhibitors. Antiplatelet agents included aspirin, clopidogrel, ticagrelor, or prasugrel. Antihypertensive medications included calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin-neprilysin inhibitor, beta blockers, nitrates, or diuretics.

  4. Number of Participants With Quality of Life (Angina Frequency) Assessment [ Time Frame: 1 year ]
    Overall health status was assessed briefly using the EQ-5D-5L, a standardized generic measure that can also be used to link specific health states to general population-based utilities. The EQ-5D-5L consists of two parts: (1) a descriptive assessment of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five responses corresponding to the level of severity within each dimension, and (2) a self-rating 0- 100 "thermometer" of current health-related quality of life. The proportion of participants with frequent angina (Seattle Angina Questionnaire angina frequency score <80).

  5. Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv) [ Time Frame: 1 year ]
    The cumulative radiation exposure over the 12 months following Randomization was calculated based on each participant's exposure to radiation for cardiovascular care. If data are missing in > 80% or more of the diagnostic and procedural testing, a single fixed estimate of radiation based on the literature will be used to impute. Given high missingness in catheterization data, a fixed estimate of 6.6 mSv and 4.1 mSv was used for catheterization with and without revascularization, respectively, based on recent trial data.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702244


Locations
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United States, Louisiana
Participating site
Lake Charles, Louisiana, United States, 70601
Sponsors and Collaborators
HeartFlow, Inc.
Duke Clinical Research Institute
Cardiovascular Research Foundation, New York
Investigators
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Principal Investigator: Pamela S Douglas Duke University
  Study Documents (Full-Text)

Documents provided by HeartFlow, Inc.:
Study Protocol  [PDF] June 29, 2018
Statistical Analysis Plan  [PDF] July 7, 2022

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HeartFlow, Inc.
ClinicalTrials.gov Identifier: NCT03702244    
Other Study ID Numbers: CP-907-001-A
First Posted: October 11, 2018    Key Record Dates
Results First Posted: December 29, 2023
Last Update Posted: December 29, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by HeartFlow, Inc.:
suspected coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases