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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Ultra High-Resolution CT scans (UHR-CT) outperform regular CT scans in detecting blocked heart arteries in individuals with possible coronary heart disease (CHD). The researchers aim to determine if this newer scan technology can provide clearer images without requiring two separate scans. Doctors have advised potential participants to undergo a CT scan due to possible CHD. As an unphased trial, participants can help advance imaging technology that may enhance heart disease diagnosis.

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 prior data suggests that Ultra High-Resolution Computed Tomography (UHR-CT) is safe for coronary heart disease patients?

Research has shown that Ultra High-Resolution CT (UHR-CT) scans are usually well-tolerated and very accurate in diagnosing heart artery disease. However, studies have found that UHR-CT scans expose patients to more radiation than regular CT scans. Despite this, patients handle UHR-CT similarly to regular CT scans.

Regular CT scans are commonly used and have a proven safety record. They are generally well-tolerated and involve less concern about radiation compared to UHR-CT.

Both UHR-CT and regular CT scans are non-invasive tests that help doctors take detailed pictures of the heart and blood vessels. While UHR-CT might provide clearer images, the main safety concern is the higher radiation level, so it's important to weigh the benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different types of CT scans to detect coronary heart disease. Unlike the standard CT scans, Ultra High-Resolution CT (UHR-CT) offers much clearer images, which can help doctors spot tiny details that might be missed otherwise. This could lead to more accurate diagnoses and better-informed treatment decisions for patients. Being able to see the heart's structure in such detail is a significant advancement, and it could mean earlier detection and intervention for coronary heart disease.

What evidence suggests that UHR-CT is effective for coronary heart disease?

This trial will compare Ultra High-Resolution CT (UHR-CT) with Conventional CT for detecting coronary heart disease (CHD). Research has shown that UHR-CT holds promise for detecting CHD. Studies indicate that UHR-CT matches the accuracy of invasive coronary angiography, a more traditional and invasive method. UHR-CT also provides clearer images of the coronary arteries, reducing errors in measuring arterial narrowing. One study found that UHR-CT could reclassify over half of patients to a lower risk category by providing more precise images. These findings suggest that UHR-CT could be a valuable tool for identifying heart disease with less invasiveness. Participants in this trial will be assigned to either the UHR-CT arm or the Conventional CT arm to evaluate these potential benefits. ^{1 6 7 8}

Who Is on the Research Team?

Joao Lima, Professor

Principal Investigator

MD

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

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]

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