ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating New Radiation Techniques for Cardiovascular Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01621594
Recruitment Status : Recruiting
First Posted : June 18, 2012
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

June 14, 2012
June 18, 2012
December 5, 2018
May 24, 2012
Not Provided
Compare time-to-first cardiovascular events (revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with greater than or equal to 50% coronary stenosis vs. <50% stenosis. [ Time Frame: 5 years ]
Thus, the specific aims of this study is 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.
Not Provided
Complete list of historical versions of study NCT01621594 on ClinicalTrials.gov Archive Site
  • Survival analysis of subjects identified by CT with significant coronary artery disease (greater than or equal to 50% stenosis) vs. subjects without significant coronary artery disease (<50% stenosis). [ Time Frame: 5 years ]
  • Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI. [ Time Frame: 90 days ]
Not Provided
Not Provided
Not Provided
 
Evaluating New Radiation Techniques for Cardiovascular Imaging
Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography

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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Participants will be enrolled at the NIH Clinical Center where a total of 3000 subjects will be enrolled. Subjects will be recruited from clinical cardiac CT referrals which generally follow published guidelines6 for appropriate use ofcardiac CT; however, these guidelines only define the most common clinical scenarios and individuals which do not fit the guidelines may have a clinical indication based on the referring physician s medical judgment. Enrolled@@@subjects must be able to travel to the NIH for study visits.
Coronary Disease
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
1500
Not Provided
Not Provided
  • INCLUSION CRITERIA:

    1. Clinical indication for a coronary CT angiography exam
    2. Age equal to or greater than 18 years
    3. Able to understand and willing to sign the Informed Consent Form
    4. Able and willing to provide follow-up information in 90 days and yearly for up to 5 years

EXCLUSION CRITERIA:

  1. Pregnancy
  2. 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)
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact: Marsha Block, R.N. (301) 496-0211 blockma@mail.nih.gov
Contact: Marcus Y Chen, M.D. (301) 496-0077 chenmy@mail.nih.gov
United States
 
 
NCT01621594
120141
12-H-0141
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Marcus Y Chen, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
November 7, 2018