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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702244
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : January 31, 2020
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 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
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

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. 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



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


Contacts
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Contact: Sarah Mullen 650-839-4012 smullen@heartflow.com
Contact: Aija Caune 650-575-6786 acaune@heartflow.com

Locations
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United States, Louisiana
Participating site Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Site Personnel         
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
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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
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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