Coronary Artery Disease
Conditions
Keywords
CCTA Coronary Artery Disease CAD
Brief summary
This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
Detailed description
285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard
Interventions
DEVICEFFR
Fractional flow reserve measured during cardiac catheterization
Sponsors
Baim Institute for Clinical Research
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Minneapolis Heart Institute Foundation
HeartFlow, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Patients providing written informed consent * Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA) * Has undergone \>64 multidetector row CCTA within 60 days prior to ICA * No cardiac interventional therapy between the CCTA and ICA
Exclusion criteria
* Prior coronary artery bypass graft (CABG) surgery * Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel * Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD * Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina) * Recent prior myocardial infarction within 40 days of ICA * Known complex congenital heart disease * Prior pacemaker or internal defibrillator lead implantation * Prosthetic heart valve * Significant arrhythmia or tachycardia * Impaired chronic renal function (serum creatinine \>1.5 mg/dl * Patients with known anaphylactic allergy to iodinated contrast * Pregnancy or unknown pregnancy status * Body mass index \>35 * Patient requires an emergent procedure * 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 III or IV) or acute pulmonary edema * Any active, serious, life-threatening disease with a life expectancy of less than 2 months * Inability to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone | 1 day | Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | 1 day | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Study Patients will receive cCTA, ICA, FFR, and cFFR per protocol.
FFR: Fractional flow reserve measured during cardiac catheterization | 252 |
| Total | 252 |
Baseline characteristics
| Characteristic | Single Arm Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 117 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants |
| Region of Enrollment Belgium | 43 Participants |
| Region of Enrollment Canada | 1 Participants |
| Region of Enrollment Latvia | 41 Participants |
| Region of Enrollment South Korea | 75 Participants |
| Region of Enrollment United States | 92 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 252 |
| serious Total, serious adverse events | 2 / 252 |
Outcome results
Primary
Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone
Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis\* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values \>0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and \<50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Study | Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone | Accuracy of FFRCT | 73 percentage of participants |
| Single Arm Study | Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone | Accuracy of CCTA | 64 percentage of participants |
Secondary
Diagnostic Performance of CCTA Plus FFRCT at the Subject Level
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Study | Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | Sensitivity | 90 percentage of participants |
| Single Arm Study | Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | Specificity | 54 percentage of participants |
| Single Arm Study | Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | Positive predictive value | 67 percentage of participants |
| Single Arm Study | Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | Negative predictive value | 84 percentage of participants |