Evaluating New Radiation Techniques for Cardiovascular Imaging

Not Applicable

Recruiting

• Conditions: Coronary Disease

• Registration Number: NCT01621594
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging

Background:

Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes.

Cardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease.

Cardiac imaging software and AI are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images.

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.

Detailed Description

Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes.

Cardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease.

Cardiac imaging software and Artificial Intelligence (AI) are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images.

Study Timeline

• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Study Start: 2012-06-21
• Status Verified: 2025-10-08
• Last Update Submitted: 2025-10-11
• Last Update Posted: 2025-10-14
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Compare time-to-first cardiovascular events (death, revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with >=50% coronary stenosis vs. <50% stenosis.	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Secondary Outcome Measures

Name	Time	Method
Compare and/or validate radiation saving techniques such as iterative reconstruction or artificial intelligence based methods against standard imaging techniques for calcium scoring.	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Evaluate natural history of coronary plaques in subjects with serial imaging if requested by ordering physician, or in subjects with >50% stenosis or high risk plaques on medical therapy.	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Estimate diagnostic accuracy of cardiovascular evaluations using current CT technology vs. invasive angiography reports/images and vs. stress perfusion MRI reports/images.	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Evaluate image quality from new CT technology.	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Survival analysis of subjects identified by CT with significant coronary artery disease (=50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis).	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.
Estimate radiation dose from clinically performed cardiovascular CT at the NIH compared to outside clinically indicated CTs.	ongoing	The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States