- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702244
The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE)
Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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Lake Charles, Louisiana, United States, 70601
- Participating site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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).
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Other: 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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Unplanned Hospitalizations (Including Admissions With Death or MI)
Time Frame: 1 year
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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).
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1 year
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Number of Catheterization and Revascularization Procedures
Time Frame: 1 year
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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.
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1 year
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Number of Participants With Preventive Medication Use
Time Frame: 1 Year
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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.
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1 Year
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Number of Participants With Quality of Life (Angina Frequency) Assessment
Time Frame: 1 year
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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).
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1 year
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Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pamela S Douglas, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-907-001-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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