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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 : Active, not recruiting
First Posted : October 11, 2018
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
Duke Clinical Research Institute
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
HeartFlow, Inc.

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE October 11, 2018
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE November 27, 2018
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2018)
Composite of Death / MI / invasive coronary angiography without obstructive disease [ Time Frame: 1 year ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Official Title  ICMJE Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: cCTA with selective FFRct
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 15, 2021)
2103
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2018)
2100
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03702244
Other Study ID Numbers  ICMJE CP-907-001-A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party HeartFlow, Inc.
Study Sponsor  ICMJE HeartFlow, Inc.
Collaborators  ICMJE
  • Duke Clinical Research Institute
  • Cardiovascular Research Foundation, New York
Investigators  ICMJE
Principal Investigator: Pamela S Douglas Duke University
PRS Account HeartFlow, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP