Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Conditions
Brief summary
This study will evaluate the level of agreement between noninvasive CCTA (coronary computed tomography angiography)-based quantification and characterization of coronary atherosclerosis and invasive IVUS (intravascular ultrasound).
Detailed description
This is a prospective, multi-center study. All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT (Fractional flow reserve-computed tomography) analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment. Enrolling sites will have FFRCT analysis incorporated when indicated into their standard evaluation of CCTA scans. Data collected will include CCTA and FFRCT, full angiographic, and IVUS images, and if obtained, any other imaging or physiologic data including OCT (Optical coherence tomography), FFR (fractional flow reserve), any NHPR (non-hyperemic pressure ratios) (e.g., dPR (diastolic pressure ratio), RFR (resting full-cycle ratio), iFR (instantaneous wave-free ratio), etc.), and pre- and post-stent implantation invasive data. All non-invasive and invasive data collected will be obtained as clinical practice consistent with standard clinical care.
Interventions
OTHERTotal Plaque Volume
Compare total plaque volume with IVUS obtained during ICA (invasive coronary angiography)
Sponsors
HeartFlow, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(all must be present): 1. Age ≥18 years 2. Clinically stable patient with known CAD 3. CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter, in whom clinically indicated IVUS is planned within 45 days of the CCTA and FFRct available 4. FFRct successfully processed 5. Willing to comply with all aspects of the protocol 6. Agrees to be included in the study and able to provide written informed consent.
Exclusion criteria
(all must be absent): 1. 1\. CCTA showing no stenosis 2. Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed. 3. Acute chest pain 4. CABG (coronary artery bypass graft) prior to CCTA acquisition 5. Prior history of PCI for 3 or more vessels 6. MI (myocardial infarction) less than 30 days prior to CCTA or between CCTA and ICA. 7. Suspicion of acute coronary syndrome (acute myocardial infarction or unstable angina) 8. Known complex congenital heart disease 9. Tachycardia or significant arrhythmia 10. Subject requires an emergent procedure 11. Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA \[New York Heart Association\] III or IV) or acute pulmonary edema 12. Any active, serious, life-threatening disease with a life expectancy of less than 2 months 13. Currently enrolled in another study utilizing FFRCT or in an investigational trial that involves a non-approved cardiac drug or device 14. Persons under the protection of justice, guardianship, or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Total Plaque Volume | 13 months | Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IVUS All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment. | 237 |
| Total | 237 |
Baseline characteristics
| Characteristic | IVUS |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 63 Participants |
| Race/Ethnicity, Customized Race Black or African American | 9 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants |
| Race/Ethnicity, Customized Race White | 157 Participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Comparison of Total Plaque Volume
Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound).
Time frame: 13 months
Population: Baseline participants is not the same as the Participant flow as 21 participants were excluded from analysis due to technical limitations and we were not able to process medical imaging data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IVUS | Comparison of Total Plaque Volume | 0.91 Pearson's correlation statistic |