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Trial record 6 of 10 for:    coronary angiography | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Evaluating New Radiation Techniques for Cardiovascular Imaging

This study is currently recruiting participants.
Verified August 24, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621594
First Posted: June 18, 2012
Last Update Posted: October 19, 2017
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.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
  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

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

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. <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 (<50% stenosis).

Estimated Enrollment: 3000
Study Start Date: May 24, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Marcus Y Chen, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01621594     History of Changes
Other Study ID Numbers: 120141
12-H-0141
First Submitted: June 14, 2012
First Posted: June 18, 2012
Last Update Posted: October 19, 2017
Last Verified: August 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
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