Trial Outcomes & Findings for Ultra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease (NCT NCT04272060)
NCT ID: NCT04272060
Last Updated: 2026-06-16
Results Overview
The primary outcome was the patient-level diagnostic accuracy of ultra-high-resolution computed tomography (UHR-CT) compared with invasive coronary angiography (ICA) for identifying hemodynamically significant coronary artery disease (CAD), using quantitative flow ratio (QFR ≤0.80) as the reference standard. For each patient, the highest-grade stenosis across all coronary vessels determined by UHR-CT and ICA was used to classify the test result. Diagnostic accuracy was defined as the percentage of correctly classified patients (true positives and true negatives) relative to QFR.
COMPLETED
NA
175 participants
Up to 90 days
2026-06-16
Participant Flow
Participant milestones
| Measure |
All Participants
All participants underwent both Research CT angiography and Conventional Angiography (conventional angiography included cardiac catheterization and invasive coronary angiography).
|
|---|---|
|
Overall Study
STARTED
|
175
|
|
Overall Study
Participants With Complete CT Scan Acquisition
|
173
|
|
Overall Study
COMPLETED
|
175
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
Baseline characteristics by cohort
| Measure |
All Participants
n=173 Participants
All participants underwent both Research CT angiography and Conventional Angiography (Conventional Angiography included standard medical care which includes cardiac catheterization and invasive coronary angiography).
|
|---|---|
|
Age, Continuous
|
66 Participant
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Sex: Female, Male
Female
|
48 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Sex: Female, Male
Male
|
125 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
Asian
|
56 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
White
|
71 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=20 Participants • Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition. To avoid unnecessary radiation exposure for research purposes, these scans were not repeated. Thus, 173 patients were included in the final analysis
|
|
BMI > 30
|
52 Participants
n=20 Participants
|
|
Hypertension
|
138 Participants
n=20 Participants
|
|
Diabetes
|
56 Participants
n=20 Participants
|
|
Dyslipidemia
|
138 Participants
n=20 Participants
|
|
Previous myocardial infarction
|
41 Participants
n=20 Participants
|
|
Prior percutaneous coronary intervention
|
58 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 90 daysPopulation: Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition.
The primary outcome was the patient-level diagnostic accuracy of ultra-high-resolution computed tomography (UHR-CT) compared with invasive coronary angiography (ICA) for identifying hemodynamically significant coronary artery disease (CAD), using quantitative flow ratio (QFR ≤0.80) as the reference standard. For each patient, the highest-grade stenosis across all coronary vessels determined by UHR-CT and ICA was used to classify the test result. Diagnostic accuracy was defined as the percentage of correctly classified patients (true positives and true negatives) relative to QFR.
Outcome measures
| Measure |
All Participants
n=173 Participants
All participants underwent both Research CT angiography and Conventional Angiography (conventional angiography included cardiac catheterization and invasive coronary angiography).
|
Conventional Angiography
n=173 Participants
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
|
|---|---|---|
|
Percentage of Correctly Classified Coronary Artery Disease Patients (True Positives and True Negatives)
|
80.3 Percentage of participants
Interval 73.6 to 86.0
|
83.2 Percentage of participants
Interval 76.8 to 88.5
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition.
Secondary outcomes included the sensitivity, specificity, and overall accuracy of UHR-CT and ICA at the patient level for detecting hemodynamically significant CAD (QFR ≤0.80). Confidence intervals were calculated using the exact binomial method, and comparisons between modalities accounted for correlated data.
Outcome measures
| Measure |
All Participants
n=173 Participants
All participants underwent both Research CT angiography and Conventional Angiography (conventional angiography included cardiac catheterization and invasive coronary angiography).
|
Conventional Angiography
n=173 Participants
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
|
|---|---|---|
|
Sensitivity, Specificity, and Accuracy of UHR-CT and ICA
Sensitivity
|
86.1 Percentage of participants
Interval 78.4 to 91.8
|
89.6 Percentage of participants
Interval 82.5 to 94.5
|
|
Sensitivity, Specificity, and Accuracy of UHR-CT and ICA
Specificity
|
69 Percentage of participants
Interval 55.5 to 80.5
|
70.7 Percentage of participants
Interval 57.3 to 81.9
|
|
Sensitivity, Specificity, and Accuracy of UHR-CT and ICA
Accuracy
|
80.3 Percentage of participants
Interval 73.6 to 86.0
|
83.2 Percentage of participants
Interval 76.8 to 88.5
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition.
The percentage of agreement between UHR-CT and ICA in classifying patients as having or not having hemodynamically significant CAD was assessed using paired comparisons of diagnostic classifications.
Outcome measures
| Measure |
All Participants
n=173 Participants
All participants underwent both Research CT angiography and Conventional Angiography (conventional angiography included cardiac catheterization and invasive coronary angiography).
|
Conventional Angiography
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
|
|---|---|---|
|
Percentage Agreement Between UHR-CT and ICA
|
80.9 Percentage of agreement
Interval 74.3 to 86.5
|
—
|
SECONDARY outcome
Timeframe: Up to 90 daysPopulation: Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition.
At the vessel level, diagnostic accuracy of UHR-CT and ICA for detecting functionally significant stenosis (QFR ≤0.80) was evaluated. A logistic regression model with generalized estimating equations assuming working independence was used to account for within-patient correlation due to multiple vessels per patient.
Outcome measures
| Measure |
All Participants
n=519 Vessels
All participants underwent both Research CT angiography and Conventional Angiography (conventional angiography included cardiac catheterization and invasive coronary angiography).
|
Conventional Angiography
n=519 Vessels
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
|
|---|---|---|
|
Accurately Detected Functionally Significant Stenosis
Specificity
|
87.8 Percentage of accurate detection
Interval 84.4 to 91.3
|
91.7 Percentage of accurate detection
Interval 89.2 to 94.3
|
|
Accurately Detected Functionally Significant Stenosis
Accuracy
|
84 Percentage of accurate detection
Interval 80.9 to 87.1
|
87.8 Percentage of accurate detection
Interval 85.2 to 90.4
|
|
Accurately Detected Functionally Significant Stenosis
Sensitivity
|
74.6 Percentage of accurate detection
Interval 67.6 to 81.4
|
78 Percentage of accurate detection
Interval 71.8 to 84.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 90 daysPopulation: Of the 175 participants who underwent both UHR-CT and ICA, and completed the study, two were excluded due to severe cardiac rhythm irregularity during scanning resulting in incomplete CT scan acquisition.
Exploratory analyses were conducted to evaluate diagnostic accuracy of UHR-CT across clinically relevant subgroups. These analyses were descriptive in nature and intended to assess consistency of performance.
Outcome measures
| Measure |
All Participants
n=173 Participants
All participants underwent both Research CT angiography and Conventional Angiography (conventional angiography included cardiac catheterization and invasive coronary angiography).
|
Conventional Angiography
n=173 Participants
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
|
|---|---|---|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patients with three vessels evaluated
|
81.5 Percentage of participants
Interval 73.9 to 87.6
|
83.0 Percentage of participants
Interval 75.5 to 88.9
|
|
Diagnostic Accuracy Across Prespecified Subgroups
CACS < 1000
|
82.6 Percentage of participants
Interval 72.9 to 89.9
|
82.6 Percentage of participants
Interval 72.9 to 89.9
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis excluding vessels with inadequate CT image quality
|
79.5 Percentage of participants
Interval 72.6 to 85.4
|
81.9 Percentage of participants
Interval 75.2 to 87.5
|
|
Diagnostic Accuracy Across Prespecified Subgroups
CACS ≥ 1000
|
78 Percentage of participants
Interval 62.7 to 90.4
|
89.5 Percentage of participants
Interval 75.2 to 97.1
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patients excluding stented vessels
|
80.2 Percentage of participants
Interval 73.5 to 85.9
|
84.3 Percentage of participants
Interval 78.0 to 89.4
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis using vessel-level QFR as a reference standard
|
78.6 Percentage of participants
Interval 71.7 to 84.5
|
82.7 Percentage of participants
Interval 76.2 to 88.0
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis by lesion location (Proximal lesions)
|
77.5 Percentage of participants
Interval 70.5 to 83.5
|
80.3 Percentage of participants
Interval 73.6 to 86.0
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis by lesion location (Distal lesions)
|
74.3 Percentage of participants
Interval 67.0 to 80.6
|
71.9 Percentage of participants
Interval 64.6 to 78.5
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis excluding side branches
|
78.6 Percentage of participants
Interval 71.7 to 84.5
|
83.2 Percentage of participants
Interval 76.8 to 88.5
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis including side branches
|
78.9 Percentage of participants
Interval 71.8 to 84.9
|
80.1 Percentage of participants
Interval 73.1 to 86.0
|
|
Diagnostic Accuracy Across Prespecified Subgroups
Patient-level analysis in patients with ≥1 stent
|
74.6 Percentage of participants
Interval 61.6 to 85.0
|
83.1 Percentage of participants
Interval 71.0 to 91.6
|
Adverse Events
CT Angiography
Conventional Angiography
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CT Angiography
n=175 participants at risk
Research CT angiography.
|
Conventional Angiography
n=175 participants at risk
Standard medical care which includes cardiac catheterization and invasive coronary angiography.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
mild delayed reaction to the contrast agent
|
0.57%
1/175 • From day of CT scan up to 90 days
|
0.00%
0/175 • From day of CT scan up to 90 days
|
|
Blood and lymphatic system disorders
Radial access site hematoma after ICA
|
0.00%
0/175 • From day of CT scan up to 90 days
|
0.57%
1/175 • From day of CT scan up to 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place