Advanced CT Imaging Techniques for Coronary Heart Disease

Recruiting at 1 trial location

Overseen By Marcus Y Chen, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Pregnancy, Severe renal dysfunction, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new techniques for capturing heart and blood vessel images using CT scans, with a focus on reducing radiation exposure. Researchers seek to determine if these low-dose imaging methods are accurate and can predict heart disease progression. The trial will also validate new imaging software and artificial intelligence tools using the Toshiba Aquilion ONE CT system. Adults needing a coronary CT angiography exam to check for heart or blood vessel issues might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to advancements in imaging technology that could benefit future patients.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these imaging techniques are safe for cardiovascular diagnostics?

Previous studies have shown that the Toshiba Aquilion ONE CT system provides clear images for heart and blood vessel imaging. This system uses less radiation than older machines, enhancing patient safety. The FDA has approved the Aquilion ONE system, confirming it meets safety standards for medical equipment.

Research indicates that this imaging technology captures detailed pictures of the heart and arteries, aiding doctors in diagnosing heart disease effectively. Although all medical procedures carry some risk, evidence suggests that the Aquilion ONE system is generally safe for patients, with reduced concerns about radiation exposure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Toshiba Aquilion ONE CT system because it offers advanced imaging techniques for diagnosing coronary heart disease. Unlike traditional CT scanners, this system captures a comprehensive 3D image of the heart in a single rotation, significantly reducing scan time and radiation exposure. This technology promises to improve the accuracy of coronary assessments, helping doctors make quicker, more informed decisions about patient care. By potentially enhancing the clarity and detail of heart images, the Toshiba Aquilion ONE might lead to earlier and more precise diagnosis, which is a game-changer for patient outcomes.

What evidence suggests that these advanced CT imaging techniques are effective for coronary heart disease?

Research has shown that the Toshiba Aquilion ONE CT scanner, used by participants in this trial, effectively images the heart, particularly in individuals with coronary artery disease. This scanner captures a complete view of the heart in a single rotation, aiding doctors in making more accurate diagnoses. Studies have found that it displays both the arteries and blood flow through the heart, offering a comprehensive view of heart health. The scanner employs advanced technology to reduce radiation exposure while maintaining clear images. These features indicate that the Toshiba Aquilion ONE CT scanner holds promise for accurately diagnosing heart conditions with reduced risk. ^{3 4 6 7 8}

Who Is on the Research Team?

Marcus Y Chen, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a coronary CT angiography exam to check their heart or blood vessels. They must understand and sign consent, be able to follow up, and have working kidneys if using contrast. Pregnant individuals or those with severe kidney issues can't join.

Inclusion Criteria

Able and willing to provide follow-up information

I need a heart scan to check my arteries.

Able to understand and willing to sign the Informed Consent Form

Exclusion Criteria

I have severe kidney issues with a low filtration rate.

Screen Failures: Subjects who are screen failures can be re-enrolled once they meet eligibility criteria. Rescreened participants will be assigned the same participant number as for the initial screening.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Imaging

Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images.

1 day

1 visit (in-person)

Follow-up

Timing of and the need for follow-up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing.

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• The Toshiba Aquilion ONE CT system

Trial Overview Researchers are testing new low-radiation techniques in the Toshiba Aquilion ONE CT system for imaging the heart and blood vessels. Participants will undergo a detailed scan session that could use a contrast agent and will be followed up after 90 days, then yearly for five years.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Subjects with Clinical indication for a coronary CT angiography exam

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

CT coronary angiography using a 256-row detector scanner provides high diagnostic image quality in patients with atrial fibrillation, achieving a 98.2% evaluable rate of coronary artery segments.

The study demonstrated that the effective radiation dose was relatively low (3.05 mSv on average), and heart rate or heart rate variability did not significantly affect image quality, indicating the safety and efficacy of this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preliminary Study of Computed Tomography Coronary Angiography Within a Single Cardiac Cycle in Patients With Atrial Fibrillation Using 256-Row Detector Computed Tomography. Wen, B., Xu, L., Liang, J., et al.[2018]

The Angio-CT system was used in 1108 procedures, with 10% involving both CT and fluoroscopy, showing significant efficiency in performing non-complex bundled procedures in a single encounter.

Non-complex cases, such as pleural catheter placements, demonstrated a substantial reduction in room time (TRoom) and total encounter time (TEncounter), indicating that the Angio-CT system can streamline certain medical interventions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid CT-angiography (Angio-CT) for combined CT and fluoroscopic procedures in interventional radiology enhances utilization. Kwak, DH., Ahmed, O., Habib, H., et al.[2023]

The new second-generation 320-detector row CT scanner significantly reduced median radiation exposure to 0.93 mSv compared to 2.67 mSv with the first-generation scanner, making it a safer option for patients undergoing coronary CT angiography.

Despite the lower radiation doses, the image quality from the second-generation scanner was excellent, with improvements in three out of four quality indexes, demonstrating its efficacy in providing high-quality diagnostic images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Submillisievert median radiation dose for coronary angiography with a second-generation 320-detector row CT scanner in 107 consecutive patients. Chen, MY., Shanbhag, SM., Arai, AE.[2021]

Advancements in mechanical computed tomography (CT) have improved cardiac imaging, allowing for detailed visualization of coronary artery stenoses, moving beyond just detecting arterial calcifications.

Key technical factors such as slow heart rates, short scanning times, and high spatial and temporal resolution are crucial for optimizing coronary artery imaging, enhancing the ability to accurately assess heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts in multi-detector row CT evaluation of the coronary arteries: principles, techniques, and anatomy. Pannu, HK., Flohr, TG., Corl, FM., et al.[2016]

CT scanning has significantly increased due to advanced multidetector-row CT technology, raising concerns about the associated radiation exposure and its potential risks to patients.

The review discusses various clinical strategies and technological innovations aimed at reducing radiation doses during CT scans, highlighting the importance of balancing diagnostic benefits with patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation exposure and projected risks with multidetector-row computed tomography scanning: clinical strategies and technologic developments for dose reduction. Kalra, MK., Maher, MM., Rizzo, S., et al.[2019]

Multislice computed tomography (MSCT) is highly accurate for noninvasive assessment of coronary artery disease (CAD), allowing for detailed evaluation of coronary calcium scores, artery stenoses, and myocardial function.

Future advancements in CT technology may enhance coronary artery imaging capabilities, introduce new applications, and significantly reduce radiation exposure for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of multislice computed tomography in coronary artery disease. de Roos, A., Kroft, LJ., Bax, JJ., et al.[2022]

In a study involving 15,142 patients using iodixanol and 22,044 patients using iohexol for CT scans, iodixanol was associated with a higher incidence of adverse events (0.77%) compared to iohexol (0.25%), indicating a potential safety concern.

Immediate adverse events were significantly more common with iodixanol (0.50%) than iohexol (0.24%), and delayed adverse events were also more frequent with iodixanol (0.26% vs. 0.01%), suggesting that while both agents are generally safe, iodixanol may pose a greater risk of adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events with universal use of iodixanol for CT: comparison with iohexol. Ho, AL., O'Malley, ME., Tomlinson, GA.[2016]

In a study of 236 patients comparing two whole-heart coronary CT scanners, the GE Revolution CT scanner demonstrated more uniform contrast enhancement and lower image noise compared to the Toshiba Aquilion ONE Vision scanner, indicating better image quality.

The GE scanner also had a larger z-axis coverage and significantly lower radiation exposure (1.50 mSv) compared to the Toshiba scanner (1.9 mSv), making it a safer option for patients undergoing coronary computed tomographic angiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Whole Heart Computed Tomography Scanners for Image Quality Lower Radiation Dosing in Coronary Computed Tomography Angiography: The CONVERGE Registry. Patel, N., Li, D., Nakanishi, R., et al.[2020]

The introduction of 64-generation scanners has significantly improved the accuracy and reliability of diagnosing coronary artery disease, particularly through its high negative predictive value, which helps exclude the disease effectively.

Advancements in cardiac CT technology and surgical procedures, such as transcatheter aortic valve implantation (TAVI), have expanded the applications of cardiac CT in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac CT: new applications]. Pesenti-Rossi, D., Baron, N., Allouch, P., et al.[2016]

Coronary computed tomography angiography (CCTA) is a valuable tool for assessing coronary artery disease, particularly in symptomatic patients with a low to intermediate risk of obstructive disease, thanks to advancements in CT technology since its introduction in 1999.

Recent improvements in CCTA have led to excellent spatial and temporal resolution, as well as enhanced contrast resolution, while new techniques have been developed to reduce radiation exposure during cardiac CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac computed tomography technology and dose-reduction strategies. Earls, JP., Leipsic, J.[2016]

The latest 64-row CT scanners feature significant technical improvements in their X-ray tube and detector systems, enhancing their capability for coronary angiography.

New scan protocols have been developed for these advanced scanners, allowing radiologists to optimize CT studies for better diagnostic outcomes in coronary imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to coronary imaging with 64-slice computed tomography. Cademartiri, F., Runza, G., Belgrano, M., et al.[2016]

Recent advancements in cardiac computed tomography (CT) and coronary CT angiography have significantly reduced radiation exposure while enhancing image quality, particularly for patients with high heart rates or severe calcification.

Key innovations include the development of area detectors, dual-source CT technology, and iterative reconstruction algorithms, which have collectively improved the safety and efficacy of cardiac imaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical advances in cardiac CT. Achenbach, S., Kondo, T.[2012]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK202073/

Background and definition of the decision problem(s) Aquilion ONE, Toshiba Medical Systems. The Toshiba Aquilion ONE is a 640-slice CT scanner with 320 × 0.5 mm detector rows giving z-axis coverage of 160 mm.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633219300212

Comparison of Whole Heart Computed Tomography ... The aim of the current study is to investigate if IQ is different between the most scanners of GE and Toshiba broad detector scanners. Materials and Methods.

3. us.medical.canon us.medical.canon/downloads/aq-prem-cvb-cardiac

State of the Art Cardiac CT “By combining arterial data and perfusion evaluation,. Aquilion ONE may enable one-stop shop cardiac imaging for pa- tients with suspected or known coronary ...

4. nice.org.uk nice.org.uk/guidance/dg3/resources/new-generation-cardiac-ct-scanners-aquilion-one-brilliance-ict-discovery-ct750-hd-and-somatom-definition-flash-for-cardiac-imaging-in-people-with-suspected-or-known-coronary-artery-disease-in-whom-im-pdf-29270622661

New generation cardiac CT scanners (Aquilion ONE, ... The clinical outcomes assessed for people with coronary artery disease were mortality, morbidity and the percentage of correct diagnostic ...

5. dicardiology.com dicardiology.com/product/toshiba-gains-fda-clearance-aquilion-one-family-enhancements

Toshiba Gains FDA Clearance for Aquilion ONE Family ... ViSION CT Detector: This more efficient CT detector results in 40 percent better light output for better use of X-ray photons;; SUREkV: Provides automated kV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4147088/

a comparison with first generation 320-detector row CT This study aims to compare the image quality of second generation versus first generation 320-computed tomography coronary angiography ...

7. nice.org.uk nice.org.uk/guidance/mib53/resources/aquilion-prime-ct-scanner-for-imaging-coronary-artery-disease-in-adults-in-whom-imaging-is-difficult-pdf-63499224847813

Aquilion PRIME CT scanner for imaging coronary artery ... The Aquilion PRIME CT scanner can be used to perform computed tomography coronary angiography (CTCA) to diagnose or evaluate coronary artery ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2893879/

CT Coronary Angiography: 256-Slice and 320-Detector Row ... The 256-slice and 320-detector row MDCT scanners has enabled volumetric imaging of the entire heart free of stair-step artifacts at a single time point within ...