N/A
N=2,103
The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT03702244 ↗Enrolled (actual)
2,103
Serious AEs
3.3%
Results posted
Dec 2023
Primary outcome: Primary: Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease — 44; 118; 18; 12 number of events — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cCTA with selective FFRct (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HeartFlow, Inc.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease |
44; 118; 18; 12; 5; 7 | <.001 sig |
| SECONDARY Number of Unplanned Hospitalizations (Including Admissions With Death or MI) |
31; 21; 9; 5 | — |
| SECONDARY Number of Catheterization and Revascularization Procedures |
135; 177; 108; 70; 97; 54 | — |
| SECONDARY Number of Participants With Preventive Medication Use |
321; 237; 450; 365; 504; 455 | — |
| SECONDARY Number of Participants With Quality of Life (Angina Frequency) Assessment |
141; 140; 50; 40 | — |
| SECONDARY Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv) |
5.2; 4.7 | — |
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.
Eligibility Criteria
Inclusion criteria (all must be present):
- Age ≥18 years
- 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.
- If prior CV testing has occurred, it must have been performed greater than one year prior to randomization, and the following must be met:
- cCTA or invasive coronary angiography (ICA) with stenosis < 50%
- Quantified coronary artery calcium (CAC) < 100 AG
- 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
- Willingness to comply with all aspects of the protocol, including adherence to the assigned strategy and follow-up visits
- Ability to provide written informed consent
Exclusion criteria (all must be absent):
- Acute chest pain (in patients who have not been ruled out for ACS)
- Unstable clinical status
- 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
- 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
- Contraindications to cCTA including but not limited to creatinine clearance (GFR) <45 ml/min as per most recent measurement taken within 90 days
- Exceeds the site's weight or size limit for cCTA or cardiac catheterization
- Any condition leading to possible inability to comply with the protocol procedures or follow-up
- Any condition that might interfere with the study procedures or follow-up
- Enrolled in an investigational trial that involves a non-approved cardiac drug or device which has not reached its primary endpoint
- Life expectancy less than 2 years due to non-cardiovascular comorbidities
Data sourced from ClinicalTrials.gov (NCT03702244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.