Trial · NCT02499679
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
NCT02499679, Completed, HeartFlow, Inc.; results first posted 2025-07-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care. Trials, record NCT02499679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02499679
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
- NCT number
- NCT02499679
- Status
- Completed
- Enrollment
- 4,737 participants, actual
- Lead sponsor
- HeartFlow, Inc.
- Conditions
- Coronary Artery Disease
- First posted
- 2015-07-16
- Last updated
- 2025-07-30
- Results first posted
- 2025-07-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory. | at 90 days | The reclassification rate of management plans was assessed by the blinded independent review committee and local physician teams separately. These evaluations are meant to assess the potential impact of FFRCT on downstream testing and clinical decision making but were not be used to determine actual patient care. This endpoint is aimed at determining the incremental value of FFRCT over coronary CTA alone in the management of stable angina. FFRCT is non-invasive method to determine FFR which computes the hemodynamic significance of CAD (FFRCT) from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions (Taylor 2013). |
| Secondary | Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management | at 90 days | Coronary computed tomography angiography-derived fractional flow reserve resulted in revision of the clinical management plan as determined by the site investigators. |
| Secondary | Percentage of Participants With Invasive Catheterization Without Obstructive Disease | At 90 days | Invasive catheterization without obstructive disease was measured by either site read coronary angiogram showing no stenosis of ≥ 50% or no invasively-measured FFR ≤ 0.80 in a segment distal to a stenosis. |
| Secondary | Percentage of Major Adverse Coronary Events (MACE) at 90 Days | 90 days | MACE is defined as the composite rate of all cause death, non-fatal myocardial infarction (MI) and unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization. |
| Secondary | Percentage of Individual Components of MACE at 90 Days | 90 days | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization |
| Secondary | Cumulative Radiation Exposure From cCTA MilliSievert (mSv) | Baseline | Cumulative radiation exposure calculated in non-invasive coronary diagnostic tests: cCTA effective radiation dose. Effective radiation dose measured as the product of dose-length product times for conversion coefficient for the chest (K = 0.026 mSv/mGy·cm). |
| Secondary | Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan | 90 days | Resource utilization composite defined as the composite of invasive diagnostic and therapeutic coronary procedures and noninvasive cardiac testing. Site treating physician recommended clinical management strategies following coronary computed tomography angiography-derived fractional flow reserve. |
| Secondary | Percentage of Major Adverse Coronary Events (MACE) at 1 Year | 1 year | MACE is defined as the composite rate of all cause death, non-fatal myocardial infarction (MI) and unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization. |
| Secondary | Percentage of Individual Components of MACE at 1 Year | 1 year | Individual components of MACE defined as all cause death, non-fatal MI, unplanned hospitalization for ACS leading to urgent revascularization |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory. | at 90 days | The primary endpoint of reclassification between core lab CCTA alone and CCTA plus FFRCT-based management. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management | at 90 days | All participants who were enrolled in the study and received cCTA and FFRCT analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Invasive Catheterization Without Obstructive Disease | At 90 days | The rate of anatomically defined 'non-obstructive' disease at ICA (no stenosis defined as \>50% at ICA) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Major Adverse Coronary Events (MACE) at 90 Days | 90 days | MACE: Major adverse cardiac event (MI, Death, Hospitalization for ASC and urgent revascularization). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Individual Components of MACE at 90 Days | 90 days | MI - myocardial infarction ACS - acute coronary syndrome | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Radiation Exposure From cCTA MilliSievert (mSv) | Baseline | All patients referred for clinical consecutive coronary CT angiography who had FFRCT analysis performed | mSv | MEAN |
| SECONDARY | Resource Utilization at 90 Days. Site-determined Post FFRCT Treatment Plan | 90 days | All stable patients who undergo cCTA and are diagnosed with CAD. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Major Adverse Coronary Events (MACE) at 1 Year | 1 year | MACE: Major adverse cardiac event (MI, Death, Hospitalization for ASC and urgent revascularization). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Individual Components of MACE at 1 Year | 1 year | MI - myocardial infarction ACS - acute coronary syndrome | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Reclassification of CAD Management, Assessed as the Therapeutic Recommendations Made Based on Review of Coronary CTA Alone Versus CTA + FFRCT, When Available, by a Central Integration Core Laboratory. | Reclassification Rate by Core Lab | 66.9 | 95% Confidence Interval 64.8 to 67.6 | percentage of participants | |
| Percentage of Participants With Reclassification Between Investigator Management Plan Based on cCTA Alone Compared to Actual Clinical Management | Reclassification Rate by Investigator Management Plan | 63.5 | 95% Confidence Interval 62.0 to 65 | percentage of participants | |
| Percentage of Participants With Invasive Catheterization Without Obstructive Disease | ICA Patients With FFRCT >0.80 | 43.8 | percentage of participants | ||
| Percentage of Participants With Invasive Catheterization Without Obstructive Disease | ICA Patients With FFRCT ≤0.80 | 14.4 | percentage of participants | ||
| Percentage of Major Adverse Coronary Events (MACE) at 90 Days | MACE Events Within 90 Days Subject Whose FFRCT Was >0.80 | 0 | Participants | ||
| Percentage of Major Adverse Coronary Events (MACE) at 90 Days | MACE Events Within 90 Days. Patients With at Least One FFRCT Value ≤ 0.80 | 19 | Participants | ||
| Percentage of Individual Components of MACE at 90 Days | Patients With cCTA and FFRCT > 0.80 | MI | 0 | Participants | |
| Percentage of Individual Components of MACE at 90 Days | Patients With cCTA and at Least One FFRCT Value ≤ 0.80 | MI | 4 | Participants | |
| Percentage of Individual Components of MACE at 90 Days | Patients With cCTA and FFRCT > 0.80 | Urgent unplanned hospitazation for ACS and urgent revascularization. | 0 | Participants | |
| Percentage of Individual Components of MACE at 90 Days | Patients With cCTA and at Least One FFRCT Value ≤ 0.80 | Urgent unplanned hospitazation for ACS and urgent revascularization. | 5 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients Diagnosed With CAD by cCTA+FFRCT | 4,737 | |
| Overall Study | COMPLETED | All Patients Diagnosed With CAD by cCTA+FFRCT | 4,737 | |
| Overall Study | NOT COMPLETED | All Patients Diagnosed With CAD by cCTA+FFRCT | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Revascularization | Cardiac disorders | Patients Receiving cCTA and FFRCT >0.80 | 80 | 1,591 | 80 |
| other | Revascularization | Cardiac disorders | Patients Receiving cCTA and FFRCT≤0.80 | 1,036 | 3,137 | 1,036 |
| serious | Death (any cause) | Cardiac disorders | Patients Receiving cCTA and FFRCT >0.80 | 7 | 4,737 | 35 |
| serious | Death (any cause) | Cardiac disorders | Patients Receiving cCTA and FFRCT≤0.80 | 28 | 4,737 | 35 |
| serious | MI | Cardiac disorders | Patients Receiving cCTA and FFRCT >0.80 | 3 | 4,737 | 12 |
| serious | MI | Cardiac disorders | Patients Receiving cCTA and FFRCT≤0.80 | 9 | 4,737 | 12 |
| serious | ACS leading to urgent hospitalization and revascularization | Cardiac disorders | Patients Receiving cCTA and FFRCT >0.80 | 2 | 4,737 | 8 |
| serious | ACS leading to urgent hospitalization and revascularization | Cardiac disorders | Patients Receiving cCTA and FFRCT≤0.80 | 6 | 4,737 | 8 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients Receiving cCTA and FFRCT >0.80 | 7 | 4,737 |
| Total, all-cause mortality | Patients Receiving cCTA and FFRCT≤0.80 | 28 | 4,737 |
| Total, other adverse events | Patients Receiving cCTA and FFRCT >0.80 | 80 | 1,591 |
| Total, other adverse events | Patients Receiving cCTA and FFRCT≤0.80 | 1,036 | 3,137 |
| Total, serious adverse events | Patients Receiving cCTA and FFRCT >0.80 | 12 | 4,737 |
| Total, serious adverse events | Patients Receiving cCTA and FFRCT≤0.80 | 43 | 4,737 |
Source ClinicalTrials.gov
Papers7
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MACE Events at 1 Year Subject Whose FFRCT Was >0.80 vs MACE Events at 1 Year. Patients With at Least One FFRCT Value ≤ 0.80: Percentage of Major Adverse Coronary Events (MACE) at 1 Year | Trial comparisons |
| Patients Receiving cCTA and FFRCT >0.80 vs Patients Receiving cCTA and FFRCT≤0.80: deaths from any cause | Trial comparisons |
| MACE Events Within 90 Days Subject Whose FFRCT Was >0.80 vs MACE Events Within 90 Days. Patients With at Least One FFRCT Value ≤ 0.80: Percentage of Major Adverse Coronary Events (MACE) at 90 Days | Trial comparisons |
| Patients Receiving cCTA and FFRCT >0.80 vs Patients Receiving cCTA and FFRCT≤0.80: 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.
GET https://conductscience.org/api/trials/v1/NCT02499679
GET https://conductscience.org/api/trials/v1/NCT02499679/results?page=2