Evaluating New Radiation Techniques for Cardiovascular Imaging

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT01621594

Collaborator

(none)

5,000

Enrollment

Location

Arm

152

Anticipated Duration (Months)

32.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease	Device: The Toshiba Aquilion ONE CT system	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography

Actual Study Start Date :

Jul 31, 2012

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Subjects with Clinical indication for a coronary CT angiography exam	Device: The Toshiba Aquilion ONE CT system To test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.

Arm

Intervention/Treatment

Experimental: 1

Subjects with Clinical indication for a coronary CT angiography exam

Device: The Toshiba Aquilion ONE CT system

To test the diagnostic accuracy of low-radiation dose CT coronary angiography for detecting significant coronary artery stenosis and to determine the prognostic value of low-radiation dose CT coronary angiography for discriminating patient risk of death or major adverse cardiac events.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Clinical indication for a coronary CT angiography exam
Age equal to or greater than 18 years
Able to understand and willing to sign the Informed Consent Form
Able and willing to provide follow-up information

EXCLUSION CRITERIA:

Pregnancy
If receiving intravenous contrast, severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria or as reported by the clinical lab. Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula: eGFR (mL/min/1.73m2) = 175 x (standardized serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) or x 1.212 (if the subject is black)