Evaluating New Radiation Techniques for Cardiovascular Imaging

Not Applicable

Recruiting

• Conditions: Coronary Disease
• Interventions: Device: Cannon Aquilion ONE CT system

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

Brief Summary

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.

* Participants will have follow-up contact 90 days after the scan, and then yearly contact for the next 5 years.

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 new imaging methods are accurate or predict subject outcomes.

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: 2025-04-10
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• 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

Arm && Interventions

Group	Intervention	Description
1	Cannon Aquilion ONE CT system	Subjects with Clinical indication for a coronary CT angiography exam

Primary Outcome Measures

Name	Time	Method
new imaging methods are accurate or predict subject outcomes.	ongoing	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.

Secondary Outcome Measures

Name	Time	Method
Estimate radiation dose from clinically performed cardiovascular CT.	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 diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI.	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.

Trial Locations

Locations (1)

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