~650 spots leftby Apr 2027

Advanced CT Imaging Techniques for Coronary Heart Disease

Recruiting in Palo Alto (17 mi)
+1 other location
MY
Overseen byMarcus Y Chen, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Disqualifiers: Pregnancy, Severe renal dysfunction, others
No Placebo Group
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging Background: - Imaging studies such as computed tomography (CT) scans involve the use of radiation to create the pictures. Heart and blood vessel CT scans can cause high radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose. Researchers want to see how effective these new methods are in producing accurate CT scans. Objectives: - To study new ways of taking pictures of the heart or blood vessels using computed tomography. Eligibility: - Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function. * 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. The scanning session may last up to 2 hours. * 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. Further follow up will be based on reported test results.

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 data supports the effectiveness of the treatment The Toshiba Aquilion ONE CT system, Toshiba Aquilion ONE CT scanner for coronary heart disease?

Research shows that advanced CT imaging techniques, like those used in the Toshiba Aquilion ONE CT system, have improved image quality and reduced radiation exposure, making them effective for diagnosing coronary artery disease, especially in challenging cases.12345

Is the Toshiba Aquilion ONE CT scanner safe for use in humans?

Research shows that advanced CT scanners, like the Toshiba Aquilion ONE, are designed to reduce radiation exposure, which is a key safety concern. Studies have focused on optimizing radiation doses to ensure patient safety while maintaining image quality.26789

How does the treatment in the clinical trial 'Advanced CT Imaging Techniques for Coronary Heart Disease' differ from other treatments for this condition?

This treatment uses advanced CT imaging techniques, such as multislice computed tomography (MSCT) and coronary computed tomography angiography (CCTA), to noninvasively assess coronary heart disease with high accuracy. It offers unique benefits like detailed evaluation of coronary artery stenoses, bypass patency, and myocardial function, while also incorporating dose-reduction strategies to minimize radiation exposure.45101112

Research Team

MY

Marcus Y Chen, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

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.
I am 18 years old or older.
See 1 more

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

Trial Timeline

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

Treatment Details

Interventions

  • The Toshiba Aquilion ONE CT system (Radiation)
Trial OverviewResearchers 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Subjects with Clinical indication for a coronary CT angiography exam

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, MD
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3987
Patients Recruited
47,860,000+

Findings from Research

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]
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]
Technical advances in cardiac CT.Achenbach, S., Kondo, T.[2012]
Introduction to coronary imaging with 64-slice computed tomography.Cademartiri, F., Runza, G., Belgrano, M., et al.[2016]
[Cardiac CT: new applications].Pesenti-Rossi, D., Baron, N., Allouch, P., et al.[2016]
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]
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.
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]
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]
Adverse events with universal use of iodixanol for CT: comparison with iohexol.Ho, AL., O'Malley, ME., Tomlinson, GA.[2016]
Applications of multislice computed tomography in coronary artery disease.de Roos, A., Kroft, LJ., Bax, JJ., et al.[2022]
Cardiac computed tomography technology and dose-reduction strategies.Earls, JP., Leipsic, J.[2016]
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]

References

Hybrid CT-angiography (Angio-CT) for combined CT and fluoroscopic procedures in interventional radiology enhances utilization. [2023]
Comparison of Whole Heart Computed Tomography Scanners for Image Quality Lower Radiation Dosing in Coronary Computed Tomography Angiography: The CONVERGE Registry. [2020]
Technical advances in cardiac CT. [2012]
Introduction to coronary imaging with 64-slice computed tomography. [2016]
[Cardiac CT: new applications]. [2016]
Submillisievert median radiation dose for coronary angiography with a second-generation 320-detector row CT scanner in 107 consecutive patients. [2021]
A Preliminary Study of Computed Tomography Coronary Angiography Within a Single Cardiac Cycle in Patients With Atrial Fibrillation Using 256-Row Detector Computed Tomography. [2018]
Radiation exposure and projected risks with multidetector-row computed tomography scanning: clinical strategies and technologic developments for dose reduction. [2019]
Adverse events with universal use of iodixanol for CT: comparison with iohexol. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Applications of multislice computed tomography in coronary artery disease. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Cardiac computed tomography technology and dose-reduction strategies. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Current concepts in multi-detector row CT evaluation of the coronary arteries: principles, techniques, and anatomy. [2016]