Coronary Artery DiseasePRECISENCT03702244
The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
A study testing cCTA with selective FFRct in people with Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- cCTA with selective FFRct
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,103 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 20 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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.
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
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.
Read the detailed description
Objective was to test a modified initial cCTA strategy (PS) designed to improve clinical efficiency vs usual testing (UT). Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy PS or UT. PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.
- Conditions
- Coronary Artery Disease
- Being tested
- cCTA with selective FFRct
- Keywords
- suspected coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cCTA with selective FFRctDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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 | Other | 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. Receives: Diagnostic Test: cCTA with selective FFRct |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
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.
Measured: 1 year
Secondary outcomes (5)
Number of Unplanned Hospitalizations (Including Admissions With Death or MI)
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).
Measured: 1 year
Number of Catheterization and Revascularization Procedures
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.
Measured: 1 year
Number of Participants With Preventive Medication Use
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.
Measured: 1 Year
Number of Participants With Quality of Life (Angina Frequency) Assessment
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).
Measured: 1 year
Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start27 Nov 2018
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 2,103 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, Cardiovascular Research Foundation, New York
- Responsible party
- Sponsor
- Investigators
- Pamela S Douglas, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702244
- Sponsor's protocol ID
- CP-907-001-A
- Acronym
- PRECISE
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2018
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chew DS, Mark DB, Li Y, Nanna MG, Kelsey MD, Daniels MR, Davidson-Ray L, Baloch KN, Rogers C, Patel MR, Anstrom KJ, Curzen N, Vemulapalli S, Douglas PS; PRECISE Investigators. Economic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011008. doi: 10.1161/CIRCOUTCOMES.123.011008. Epub 2025 Feb 3.
PubMed 39895495Mark DB, Li Y, Nanna MG, Kelsey MD, Daniels MR, Rogers C, Patel MR, Baloch KN, Chow BJW, Anstrom KJ, Vemulapalli S, Weir-McCall JR, Stone GW, Chew DS, Douglas PS; PRECISE Investigators. Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011414. doi: 10.1161/CIRCOUTCOMES.124.011414. Epub 2025 Feb 3.
PubMed 39895494Udelson JE, Kelsey MD, Nanna MG, Fordyce CB, Yow E, Clare RM, Mark DB, Patel MR, Rogers C, Curzen N, Pontone G, Maurovich-Horvat P, De Bruyne B, Greenwood JP, Marinescu V, Leipsic J, Stone GW, Ben-Yehuda O, Berry C, Hogan SE, Redfors B, Ali ZA, Byrne RA, Kramer CM, Yeh RW, Martinez B, Mullen S, Huey W, Anstrom KJ, Al-Khalidi HR, Chiswell K, Vemulapalli S, Douglas PS; PRECISE Investigators. Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease: A Prespecified Secondary Analysis of the PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):915-924. doi: 10.1001/jamacardio.2023.2614.
PubMed 37610768Douglas PS, Nanna MG, Kelsey MD, Yow E, Mark DB, Patel MR, Rogers C, Udelson JE, Fordyce CB, Curzen N, Pontone G, Maurovich-Horvat P, De Bruyne B, Greenwood JP, Marinescu V, Leipsic J, Stone GW, Ben-Yehuda O, Berry C, Hogan SE, Redfors B, Ali ZA, Byrne RA, Kramer CM, Yeh RW, Martinez B, Mullen S, Huey W, Anstrom KJ, Al-Khalidi HR, Vemulapalli S; PRECISE Investigators. Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):904-914. doi: 10.1001/jamacardio.2023.2595.
PubMed 37610731Nanna MG, Vemulapalli S, Fordyce CB, Mark DB, Patel MR, Al-Khalidi HR, Kelsey M, Martinez B, Yow E, Mullen S, Stone GW, Ben-Yehuda O, Udelson JE, Rogers C, Douglas PS. The prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization: Rationale and design of the PRECISE trial. Am Heart J. 2022 Mar;245:136-148. doi: 10.1016/j.ahj.2021.12.004. Epub 2021 Dec 23.
PubMed 34953768
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
- ClinicalTrials.gov ID
- NCT03702244
- Acronym / sponsor ID
- PRECISE / CP-907-001-A
- Conditions
- Coronary Artery Disease
- Keywords
- suspected coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,103 participants (actual)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, Cardiovascular Research Foundation, New York
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 29 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Objective was to test a modified initial cCTA strategy (PS) designed to improve clinical efficiency vs usual testing (UT). Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy PS or UT. PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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 | Other | Diagnostic Test: cCTA with selective FFRctParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Safe performance of cCTA:
- Willingness to comply with all aspects of the protocol, including adherence to the assigned strategy and follow-up visits
Key exclusion criteria (11 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cCTA with selective FFRctPRECISE 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 | Diagnostic test | Precision evaluation |
Primary outcome
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
Time frame: 1 year
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.
5 secondary outcomes
Number of Unplanned Hospitalizations (Including Admissions With Death or MI)
Time frame: 1 year
Number of Catheterization and Revascularization Procedures
Time frame: 1 year
Number of Participants With Preventive Medication Use
Time frame: 1 Year
Number of Participants With Quality of Life (Angina Frequency) Assessment
Time frame: 1 year
Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39895495Chew DS, Mark DB, Li Y, Nanna MG, Kelsey MD, Daniels MR, Davidson-Ray L, Baloch KN, Rogers C, Patel MR, Anstrom KJ, Curzen N, Vemulapalli S, Douglas PS; PRECISE Investigators. Economic Outcomes With Precision Diagnostic Testing Versus Usual Testing in Stable Chest Pain: Results From the PRECISE Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011008. doi: 10.1161/CIRCOUTCOMES.123.011008. Epub 2025 Feb 3.
- Derived from this study: PubMed 39895494Mark DB, Li Y, Nanna MG, Kelsey MD, Daniels MR, Rogers C, Patel MR, Baloch KN, Chow BJW, Anstrom KJ, Vemulapalli S, Weir-McCall JR, Stone GW, Chew DS, Douglas PS; PRECISE Investigators. Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011414. doi: 10.1161/CIRCOUTCOMES.124.011414. Epub 2025 Feb 3.
- Derived from this study: PubMed 37610768Udelson JE, Kelsey MD, Nanna MG, Fordyce CB, Yow E, Clare RM, Mark DB, Patel MR, Rogers C, Curzen N, Pontone G, Maurovich-Horvat P, De Bruyne B, Greenwood JP, Marinescu V, Leipsic J, Stone GW, Ben-Yehuda O, Berry C, Hogan SE, Redfors B, Ali ZA, Byrne RA, Kramer CM, Yeh RW, Martinez B, Mullen S, Huey W, Anstrom KJ, Al-Khalidi HR, Chiswell K, Vemulapalli S, Douglas PS; PRECISE Investigators. Deferred Testing in Stable Outpatients With Suspected Coronary Artery Disease: A Prespecified Secondary Analysis of the PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):915-924. doi: 10.1001/jamacardio.2023.2614.
- Derived from this study: PubMed 37610731Douglas PS, Nanna MG, Kelsey MD, Yow E, Mark DB, Patel MR, Rogers C, Udelson JE, Fordyce CB, Curzen N, Pontone G, Maurovich-Horvat P, De Bruyne B, Greenwood JP, Marinescu V, Leipsic J, Stone GW, Ben-Yehuda O, Berry C, Hogan SE, Redfors B, Ali ZA, Byrne RA, Kramer CM, Yeh RW, Martinez B, Mullen S, Huey W, Anstrom KJ, Al-Khalidi HR, Vemulapalli S; PRECISE Investigators. Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023 Oct 1;8(10):904-914. doi: 10.1001/jamacardio.2023.2595.
- Derived from this study: PubMed 34953768Nanna MG, Vemulapalli S, Fordyce CB, Mark DB, Patel MR, Al-Khalidi HR, Kelsey M, Martinez B, Yow E, Mullen S, Stone GW, Ben-Yehuda O, Udelson JE, Rogers C, Douglas PS. The prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization: Rationale and design of the PRECISE trial. Am Heart J. 2022 Mar;245:136-148. doi: 10.1016/j.ahj.2021.12.004. Epub 2021 Dec 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela S Douglas principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cCTA with selective FFRct in people with Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702244, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.