UHR-CT vs Conventional CT for Coronary Heart Disease

Overseen By Joao Lima, Professor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Atrial fibrillation, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of this treatment for coronary heart disease?

Research shows that ultra-high-resolution CT (UHR-CT) provides better visualization of coronary arteries, especially in cases with severe calcification, compared to conventional CT. This improved imaging can help doctors more accurately assess and diagnose coronary heart disease. ^{1 2 3 4 5}

Is Ultra High-Resolution CT (UHR-CT) safe for humans?

Research shows that Ultra High-Resolution CT (UHR-CT) scans provide high-quality images at moderate radiation levels, which are considered acceptable for medical imaging. Studies have demonstrated that UHR-CT can effectively capture detailed images of small structures in the body, such as blood vessels and bones, while maintaining a safe radiation dose. ^{1 6 7 8 9}

How does Ultra High-Resolution CT differ from conventional CT for coronary heart disease?

Ultra High-Resolution CT (UHR-CT) offers improved visualization of calcified and stented vessels in the heart, which can be challenging to assess with conventional CT. This makes it particularly useful for evaluating severe coronary artery calcification, although it may result in increased noise and radiation exposure. ^{2 3 4 10 11}

Research Team

Joao Lima, Professor

Principal Investigator

MD

Eligibility Criteria

This trial is for individuals with various forms of heart disease, including coronary artery disease and myocardial ischemia. Participants should be generally at lower risk to assess the effectiveness of a new Ultra High-Resolution CT scan compared to conventional CT scans.

Inclusion Criteria

I am between 21 and 85 years old.

Ability to understand and willingness to sign the Informed Consent Form

My cardiologist referred me for a CTA scan due to suspected coronary heart disease.

Exclusion Criteria

Presence of any other history or condition that the investigator feels would be problematic

I have had multiple myeloma or an organ transplant.

My kidney function is reduced, with high creatinine or low clearance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo CT scans using either Conventional Resolution CT or Ultra-High-Resolution CT imaging modalities

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

24 months

Treatment Details

Interventions

• Conventional Computed Tomography
• Ultra High-Resolution Computed Tomography (UHR-CT)

Trial Overview The CORE-COMPARE study is testing whether an advanced scanning technology called Ultra High-Resolution Computed Tomography (UHR-CT) can better identify blockages in the heart's arteries than standard CT scans without exposing patients to additional scans.

Participant Groups

Group I: UHR-CT (Ultra-High-Resolution Computed Tomography-Aquilion Precision) Experimental Treatment 1 Intervention

Participants in this arm undergo CT scans using the Ultra-High-Resolution CT imaging modality.

Group II: CR-CT (Conventional Resolution Computed Tomography) Active Control 1 Intervention

Participants in this arm receive CT scans using the Conventional Resolution CT imaging modality.

Conventional Computed Tomography is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Computed Tomography for:

• Diagnostic imaging for various conditions including cardiovascular diseases, lung diseases, and abdominal conditions

Approved in United States as Computed Tomography for:

• Diagnostic imaging for various conditions including cardiovascular diseases, lung diseases, abdominal conditions, and cancer screening

Approved in Canada as Computed Tomography for:

• Diagnostic imaging for various conditions including cardiovascular diseases, lung diseases, and abdominal conditions

Approved in Japan as Computed Tomography for:

• Diagnostic imaging for various conditions including cardiovascular diseases, lung diseases, and abdominal conditions

Approved in China as Computed Tomography for:

• Diagnostic imaging for various conditions including cardiovascular diseases, lung diseases, and abdominal conditions

Approved in Switzerland as Computed Tomography for:

• Diagnostic imaging for various conditions including cardiovascular diseases, lung diseases, and abdominal conditions

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Canon Medical Systems, USA

Industry Sponsor

Trials

14

Recruited

1,300+

Findings from Research

Ultra-high resolution (UHR) scan mode in ultra-low dose photon-counting detector CT (PCD-CT) significantly reduces image noise compared to standard resolution mode, enhancing image quality while maintaining low radiation exposure.

In a study involving six cadaveric specimens and assessments by 16 medical professionals, UHR images were preferred in most comparisons, indicating its potential for improved diagnostic capabilities in lung imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the Small Pixel Effect in Ultra-High Resolution Photon-Counting CT of the Lung. Huflage, H., Hendel, R., Kunz, AS., et al.[2023]

Ultra-high-resolution (UHR) CT enhances the visualization of calcified and stented vessels in cardiac imaging, although it may lead to increased noise and radiation exposure.

Photon-counting CT and phase-contrast CT represent significant advancements, with photon-counting CT reducing artifacts and improving contrast resolution, while phase-contrast CT enhances spatial and soft-tissue contrast, making them valuable for cardiovascular imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-Generation Hardware Advances in CT: Cardiac Applications. Kwan, AC., Pourmorteza, A., Stutman, D., et al.[2022]

Ultra-high-resolution CT (UHR-CT) shows promise in accurately assessing severely calcified coronary artery lesions, achieving a sensitivity of 86% and specificity of 88% when compared to invasive angiography in a study of 15 patients aged 45 and older.

Despite higher image noise levels with UHR-CT, diagnostic confidence remained high, suggesting that UHR-CT could be a valuable tool for improving the evaluation of coronary artery stenosis in patients with significant calcification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-High-Resolution Coronary CT Angiography for Assessment of Patients with Severe Coronary Artery Calcification: Initial Experience. Latina, J., Shabani, M., Kapoor, K., et al.[2022]

Coronary CT angiography (CCTA) using ultra-high-resolution computed tomography (U-HRCT) showed a remarkable sensitivity of 100% for detecting coronary artery disease (CAD) in a study of 38 patients, indicating its high efficacy as a diagnostic tool.

CCTA demonstrated excellent correlation with invasive coronary angiography (ICA) in measuring the percentage of artery stenosis, with a correlation coefficient of 0.90, although it slightly overestimated stenosis by an average of 4%, suggesting it is a reliable method for assessing coronary artery conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of coronary CT angiography with ultra-high-resolution CT: Comparison with invasive coronary angiography. Takagi, H., Tanaka, R., Nagata, K., et al.[2022]

Photon-counting computed tomography (PCCT) with ultra-high-resolution (UHR) scanning significantly enhances the ability of radiologists to detect and analyze small anatomical abnormalities in the lungs, such as those in secondary pulmonary lobules.

UHR protocols not only improve the evaluation of noncontrast chest CTs but also enhance chest CT angiographic examinations, providing better morphological assessments and higher-quality lung perfusion imaging while potentially reducing radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-High-Resolution Photon-Counting CT Imaging of the Chest: A New Era for Morphology and Function. Remy-Jardin, M., Hutt, A., Flohr, T., et al.[2023]

The Comb-UHR CT scanner demonstrated a 70% dose efficiency compared to the routine scan mode (RS) and provided over two times better performance than the Detector-UHR scanner, indicating it may be more effective in minimizing radiation exposure while maintaining image quality.

Despite both ultra-high-resolution modes achieving high system performance, they did not show significant advantages over the routine scan mode for abdominal CT angiography due to insufficient dose efficiencies, suggesting that routine scans may still be preferable in certain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Note: Performance comparison of ultra-high-resolution scan modes of two clinical computed tomography systems. Kawashima, H., Ichikawa, K., Takata, T., et al.[2020]

Ultra-high resolution cerebral CT angiography (UHR-CTA) provides excellent image quality and high contrast-to-noise ratios, making it effective for visualizing small cerebral vessels and pathologies, as assessed in a study of 50 patients.

The radiation exposure from UHR-CTA is moderate, with an effective dose of 2.5 ± 0.6 mSv, indicating that it is a safe imaging option while still delivering high diagnostic value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Ultra-High Resolution Supra-Aortic CT Angiography: An Assessment of Diagnostic Image Quality and Radiation Dose. Ucar, FA., Frenzel, M., Abello Mercado, MA., et al.[2022]

The ultrahigh-resolution (UHR) photon counting detector (PCD) computed tomography system demonstrated nearly equivalent spatial resolution compared to a conventional energy-integrating detector (EID) system, achieving high clarity in imaging small structures.

The PCD system produced images with 29% lower noise than the EID system, suggesting that it could allow for a 50% reduction in radiation dose while maintaining similar image quality, which is significant for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-efficient ultrahigh-resolution scan mode using a photon counting detector computed tomography system. Leng, S., Yu, Z., Halaweish, A., et al.[2020]

Ultrahigh-resolution CT (U-HRCT) significantly improves the visibility of key anatomic structures in the temporal bone compared to conventional multi-detector row CT (ConvCT), particularly for the stapedius tendon, which was rated much clearer (p < 0.0001).

In a study involving 30 patients, U-HRCT demonstrated excellent interobserver agreement (κ = 0.920) for anatomical visibility, suggesting it may enhance surgical planning and decision-making in otology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrahigh-resolution CT scan of the temporal bone. Yamashita, K., Hiwatashi, A., Togao, O., et al.[2018]

Ultra-high-resolution computed tomography (U-HRCT) in super-high resolution (SHR) mode provides a more accurate quantification of coronary artery calcium (CAC) volume compared to conventional CT, with a lower mean error value in phantom studies.

In cadaver scans, SHR mode detected a significantly higher mean CAC volume than conventional mode, suggesting that SHR imaging enhances the visualization of small calcifications, which is crucial for accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of coronary artery calcium volume using ultra-high-resolution computed tomography: A preliminary phantom and cadaver study. Fukumoto, W., Nagaoka, M., Higaki, T., et al.[2022]

Ultra-high-resolution CT (U-HRCT) significantly improves the visualization of in-stent restenosis compared to conventional-resolution CT (CRCT), showing wider lumen sizes and narrower stent strut thickness across various reconstruction methods.

The image quality of U-HRCT is notably better than CRCT, with a visual score of 3.2 compared to 2.0, indicating that U-HRCT is more effective for assessing stent conditions, although the angle of the stent can influence image quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of visibility of in-stent restenosis between conventional- and ultra-high spatial resolution computed tomography: coronary arterial phantom study. Nishii, T., Funama, Y., Kato, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Investigating the Small Pixel Effect in Ultra-High Resolution Photon-Counting CT of the Lung. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Next-Generation Hardware Advances in CT: Cardiac Applications. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Ultra-High-Resolution Coronary CT Angiography for Assessment of Patients with Severe Coronary Artery Calcification: Initial Experience. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Diagnostic performance of coronary CT angiography with ultra-high-resolution CT: Comparison with invasive coronary angiography. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultra-High-Resolution Photon-Counting CT Imaging of the Chest: A New Era for Morphology and Function. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Technical Note: Performance comparison of ultra-high-resolution scan modes of two clinical computed tomography systems. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Ultra-High Resolution Supra-Aortic CT Angiography: An Assessment of Diagnostic Image Quality and Radiation Dose. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Dose-efficient ultrahigh-resolution scan mode using a photon counting detector computed tomography system. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Ultrahigh-resolution CT scan of the temporal bone. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Measurement of coronary artery calcium volume using ultra-high-resolution computed tomography: A preliminary phantom and cadaver study. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

Comparison of visibility of in-stent restenosis between conventional- and ultra-high spatial resolution computed tomography: coronary arterial phantom study. [2022]