Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canon Medical Systems, USA | INDUSTRY |
Not provided
Not provided
The utility of Ultra High-Resolution Computed Tomography (UHR-CT) compared to conventional CT in all-comers (i.e., a generally lower-risk population) remains uncertain but is an important area of study in order to justify wider spread implementation and use of this technology, particularly in light of reports of significantly higher radiation exposure with UHR-CT, as well as longer scan times. The availability of technology to reconstruct conventional resolution (CR) simulation images from the raw CT acquisition data acquired on the UHR-CT scanner offers a unique platform to study this question without subjecting individuals to two different scans.
The primary objective of this study is to generate preliminary data in support of the hypothesis that noninvasive UHR-CT is superior to conventional resolution CT for identifying patients with obstructive CHD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision) | Experimental | Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality. |
|
| CR-CT (Conventional Resolution Computed Tomography) | Active Comparator | Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquilion Precision | Device | Ultra-High Resolution CT (UHR CT) capable of resolving anatomy as small as 150 microns, providing CT image quality with resolution typically seen only in cath labs. The UHR detector is newly designed to provide more than twice the resolution when compared with today's CT technology, with an all-new detector as well as tube, gantry and reconstruction technologies. |
| Measure | Description | Time Frame |
|---|---|---|
| agreement between the number of patients with >70% stenosis detected by ultra-high-resolution tomography compared to conventional tomography, with catheterization considered as the gold standard. | The ultra-high-resolution CT images (UHRCT) and the reconstructed conventional CT resolution images (CRCT) will be independently reviewed by two observers (with a 60-day washout period between both images). The stenoses will be classified according to the Society of Cardiovascular Computed Tomography (SCCT) classification system (<25%, 25-49%, 50-69%, 70-99%, and occluded). Patients with stenosis greater than 70% will be flagged. The primary outcome will be assessed for patients that underwent a clinically indicated invasive angiography (ICA). To compare agreement between UHRCT and CRCT studies while using ICA as the gold-standard, a concordance meta-analysis will be employed. This involves evaluating the agreement measures from each study, standardizing the results, and then comparing the concordance results of the two studies with the third study, considered the gold standard. | Up to 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Segment-Based Analysis for Obstructive Stenosis: | Stenosis greater than 70% and 50-69% will be identified and flagged in both imaging modalities (UHRCT and CRCT). The agreement in identifying these specific levels of stenosis will be compared. | Up to 24 Months |
| Diagnostic Confidence Assessment: |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joao Lima, Professor | Contact | 4106141284 | jlima@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joao Lima, Professor | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Recruiting | Baltimore | Maryland | 21205 | United States |
Not provided
Data requests can be submitted starting 12 months after article publication. Data will be made accessible up to 24 months with extensions considered as needed.
Access provided upon request.
Not provided
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
blinded, prospective single-center study.
Not provided
Not provided
Not provided
|
| Conventional Computed Tomography | Device | Conventional reconstruction Computed Tomography (CT) represents a pivotal approach in medical imaging. |
|
Confidence level will be classified by the 2 observers for both imaging modalities using the following scale: 1. Very Unsure, 2. Unsure, 3. Moderately Confident, 4. Confident, 5. Highly Confident. |
| Up to 24 Months |
| Interobserver Variability Analysis: | The agreement in the stenosis classification at patient and vessel level will be assessed using Cohen's kappa statistic. | Up to 24 Months |
| Assessment of vascular and plaque metrics: | A comparison will be performed between both imaging modalities for the following parameters: vessel volume, lumen volume, wall/lumen ratio, total plaque volume, percentage of calcified component, percentage of non-calcified component. | Up to 24 Months |
| Pericoronary Adipose Tissue Analysis: | The perivascular fat attenuation index (FAI) will be calculated for all the three major vessels, right coronary artery (RCA), left circumflex artery (LCX) and left anterior descending (LAD) in both datasets and the results will be compared. | Up to 24 Months |