Trial · NCT03702244
The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
NCT03702244, Not applicable, Completed, HeartFlow, Inc.; results first posted 2023-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization. Trials, record NCT03702244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03702244
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
- NCT number
- NCT03702244
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,103 participants, actual
- Lead sponsor
- HeartFlow, Inc.
- Conditions
- Coronary Artery Disease
- Interventions
- cCTA with selective FFRct
- First posted
- 2018-10-11
- Last updated
- 2023-12-29
- Results first posted
- 2023-12-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | 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. |
| Secondary | Number of Unplanned Hospitalizations (Including Admissions With Death or MI) | 1 year | 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). |
| Secondary | Number of Catheterization and Revascularization Procedures | 1 year | 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. |
| Secondary | Number of Participants With Preventive Medication Use | 1 Year | 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. |
| Secondary | Number of Participants With Quality of Life (Angina Frequency) Assessment | 1 year | 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). |
| Secondary | Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv) | 1 year | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | 1 year | Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events. The primary endpoint of this study is estimated as time to first occurrence of any of its three following components: All-cause death; Non-fatal MI; Invasive cardiac catheterization without obstructive CAD. | number of events | NUMBER |
| SECONDARY | Number of Unplanned Hospitalizations (Including Admissions With Death or MI) | 1 year | For All Cause Hospitalization only a descriptive summary will be presented. | number of events | NUMBER |
| SECONDARY | Number of Catheterization and Revascularization Procedures | 1 year | Additionally catheterization efficiency or cath yield is defined as the proportion of participants with an invasive coronary angiogram who underwent revascularization within 6 months of catheterization. Rates will be summarized by 2 groups. | number of events | NUMBER |
| SECONDARY | Number of Participants With Preventive Medication Use | 1 Year | The number (%) will be summarized between the precision care arm and usual care arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Quality of Life (Angina Frequency) Assessment | 1 year | Angina Frequency Score at Baseline was used as reference. Not all participants fully completed the questionnaire, therefore data were collected as presented below. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv) | 1 year | In instances in which sufficient information required to assess actual dose is not available, data were imputed. For CCTA and nuclear imaging missing values were imputed based on distribution of data from participants. Cumulative radiation exposure from additional cardiac testing and procedures during the entire follow-up period were also collected or estimated based on accepted average exposures. Given high missingness in catheterization data, a fixed estimate of 6.6 mSv and 4.1 mSv was used. | mSv | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Precision Strategy (PS) | Primary Composite End Point | 44 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Usual Testing (UT) | Primary Composite End Point | 118 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Precision Strategy (PS) | Death or Nonfatal Myocardial Infarction (first event only) | 18 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Usual Testing (UT) | Death or Nonfatal Myocardial Infarction (first event only) | 12 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Precision Strategy (PS) | Death from any cause | 5 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Usual Testing (UT) | Death from any cause | 7 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Precision Strategy (PS) | Nonfatal Myocardial Infarction | 13 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Usual Testing (UT) | Nonfatal Myocardial Infarction | 5 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Precision Strategy (PS) | Invasive cardiac catheterization without Obstructive coronary disease | 27 | number of events | |
| Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease | Usual Testing (UT) | Invasive cardiac catheterization without Obstructive coronary disease | 107 | number of events |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Precision Strategy (PS) | 1,057 | |
| Overall Study | STARTED | Usual Testing (UT) | 1,046 | |
| Overall Study | COMPLETED | Precision Strategy (PS) | 1,057 | |
| Overall Study | COMPLETED | Usual Testing (UT) | 1,046 | |
| Overall Study | NOT COMPLETED | Precision Strategy (PS) | 0 | |
| Overall Study | NOT COMPLETED | Usual Testing (UT) | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HeartFlow Analysis (FFRCT) - Customer Support Investigations | Product Issues | Precision Strategy (PS) | 0 | 1,057 | 0 |
| other | HeartFlow Analysis (FFRCT) - Customer Support Investigations | Product Issues | Usual Testing (UT) | 0 | 1,046 | 0 |
| other | Major test and procedural complications by test type | Injury, poisoning and procedural complications | Precision Strategy (PS) | 4 | 1,057 | 4 |
| other | Major test and procedural complications by test type | Injury, poisoning and procedural complications | Usual Testing (UT) | 6 | 1,046 | 6 |
| other | Minor test and procedural complications by test type | Injury, poisoning and procedural complications | Precision Strategy (PS) | 9 | 1,057 | 9 |
| other | Minor test and procedural complications by test type | Injury, poisoning and procedural complications | Usual Testing (UT) | 37 | 1,046 | 37 |
| serious | Myocardial Infarction (MI - non-fatal) | Cardiac disorders | Precision Strategy (PS) | 13 | 1,057 | 13 |
| serious | Myocardial Infarction (MI - non-fatal) | Cardiac disorders | Usual Testing (UT) | 5 | 1,046 | 5 |
| serious | Death from any cause | Cardiac disorders | Precision Strategy (PS) | 5 | 1,057 | 5 |
| serious | Death from any cause | Cardiac disorders | Usual Testing (UT) | 7 | 1,046 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Precision Strategy (PS) | 5 | 1,057 |
| Total, all-cause mortality | Usual Testing (UT) | 7 | 1,046 |
| Total, other adverse events | Precision Strategy (PS) | 13 | 1,057 |
| Total, other adverse events | Usual Testing (UT) | 43 | 1,046 |
| Total, serious adverse events | Precision Strategy (PS) | 40 | 1,057 |
| Total, serious adverse events | Usual Testing (UT) | 30 | 1,046 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Precision Strategy (PS) vs Usual Testing (UT): deaths from any cause | Trial comparisons |
| Precision Strategy (PS) vs Usual Testing (UT): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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