Principal Investigator: Majd Ibrahim
Keywords: heart , revascularization Department: Cardiovascular Medicine
IRB Number: 00123318
Specialty: Cardiology, Cardiology
Sub Specialties: Body Imaging, Cardiac Imaging
Recruitment Status: Recruiting

Contact Information

Jeff  Gibbs
jeffrey.gibbs@hsc.utah.edu
801-587-4877

Brief Summary

The primary objective of the PRECISE trial is to assess clinical outcomes, decision making regarding noninvasive testing and invasive angiography, and costs using a precision evaluation strategy as compared to a usual care strategy in participants with stable symptoms suggestive of coronary artery disease. The precision evaluation strategy will be based on a pre-test risk assessment and will incorporate cCTA with selective FFRCT and guideline-recommended care with symptom and risk factor management and no immediately planned testing

The sponsor of this study is a company called HeartFlow, Inc., which has developed a new technology called Computed Fractional Flow Reserve (FFRCT). The FFRCT software is applied to the results of standard cCTA scans, or heart scans, to assist doctors in evaluating the significance of blockages in the arteries of the heart.  This technology is commercially available in USA, Canada, Europe and Japan. .  Please refer to attached 510(k) letter for HeartFlow’s FFRCT (24Aug2016); which is a Coronary Physiologic Simulation Software Device being used in accordance to its indications for use. 

The PROMISE Risk tool uses readily available clinical data such as tobacco usage, ethnicity/race, and age to assign risk within Precision Arm patients to either low or elevated risk.  The PROMISE risk score  has been used and validated previously (not developed for the sole purpose of the current trial).  Please refer to the following reference related to the derivation and validation of the PROMISE Risk Score cited in the protocol (v4, ref. 34): Fordyce CB, Douglas PS, Roberts RS, Hoffmann U, Al-Khalidi HR, Patel MR, Granger CB, Kostis J, Mark DB, Lee KL, Udelson JE; Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Investigators. Identification of patients with stable chest pain deriving minimal value from noninvasive testing: The PROMISE Minimal-Risk Tool, A secondary analysis of a randomized clinical trial. JAMA Cardiol. 2017; 2(4):400-408. doi: 10.1001/jamacardio.2016.5501. PMID: 28199464. 

 If sites were aware of the risk score in usual care participants, then it is possible that ‘usual care’ strategies may be affected and render the study invalid.

Inclusion Criteria

Inclusion criteria (all must be present):
1. Age ≥18 years


2. Stable typical or atypical symptoms suggesting possible coronary artery disease (CAD) with further non-emergent testing or elective catheterization recommended to evaluate the presence of suspected CAD. Stable chest pain 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:
a. cCTA or invasive coronary angiography (ICA) with stenosis < 50%
b. Quantified coronary artery calcium (CAC) < 100 AG


4. 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


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

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. -       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