Evaluating New Radiation Techniques for Cardiovascular Imaging

This study is currently recruiting participants.
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01621594
First received: June 14, 2012
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

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
Coronary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Compare time-to-first cardiovascular events (revascularization more than 90 days after CTA, hospitalization, non-fatal myocardial infarction, stroke) in subjects with (Degree)(SqrRoot) 50% coronary stenosis vs. & lt; 50% stenosis.

Secondary Outcome Measures:
  • Survival analysis of subjects identified by CT with significant coronary artery disease ( (Degree)(SqrRoot) 50% stenosis) vs. subjects without significant coronary artery disease (& lt; 50% stenosis).

Estimated Enrollment: 1500
Study Start Date: May 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621594

Contacts
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

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Marcus Y Chen, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01621594     History of Changes
Other Study ID Numbers: 120141, 12-H-0141
Study First Received: June 14, 2012
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cardiac
Computed Tomography
Radiation Reduction
Iterative Reconstruction

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 20, 2014