We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 11 for:    Coronary Angiography | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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 : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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.

Condition or disease
Coronary Disease

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 Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of New Techniques in Radiation Reduction for Cardiovascular Computed Tomographic Angiography
Study Start Date : May 24, 2012



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Estimate diagnostic accuracy of cardiovascular evaluations using new CT technology vs. invasive angiography and versus stress perfusion MRI. [ Time Frame: 90 days ]


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 to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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)

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)

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 Posted: June 18, 2012    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: December 29, 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