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Prospective International Study of Coronary Subtraction Using 320 Detector Row CT (CorSub)

This study is currently recruiting participants.
Verified September 14, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02303067
First Posted: November 27, 2014
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

Background:

- This study is designed for people who need a standard, non-research invasive coronary angiogram to find out if they have heart disease. Researchers want to take a computed tomography (CT) scan of people s hearts before their procedure to see if this less invasive test can also diagnose coronary artery disease.

Objectives:

- To learn if a new way to view CT pictures is able to accurately diagnose coronary artery disease.

Eligibility:

- People age 55 and older who need a coronary angiogram.

Design:

  • Participants will be screened with their medical records.
  • Participants may give a blood sample.
  • Participants may have a CT scan of the heart with and without contrast. The CT scan will not interfere with their medical care.
  • Participants blood pressure and heart rhythm will be monitored before, during, and after the CT scan. They may have an electrocardiogram.
  • Before the scan, participants will have an intravenous catheter put into their arm. It will be used to inject contrast.
  • Participants may take a beta blocker to slow their heart rate.
  • Participants may take nitroglycerin under their tongue. It will enlarge their heart blood vessels and improve picture quality. It may cause a flushing sensation or headache.
  • Participants will lie on their back on a padded table. The table slides into a large, donut-shaped machine. An x-ray tube will move around their body, taking pictures. They will be asked to hold their breath for 5 seconds at a time.
  • Participants will be called 30 days after their angiogram. They will answer questions about their health, hospital visits, or medical treatments.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective International Study of Coronary Subtraction Using 320 Row-Detector CT

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Coronary substraction CCTA improves the diagnostic accuracy. [ Time Frame: 3 months ]

Estimated Enrollment: 125
Study Start Date: January 6, 2015
Estimated Study Completion Date: April 1, 2018
Estimated Primary Completion Date: April 1, 2018 (Final data collection date for primary outcome measure)
Detailed Description:

Coronary calcium can impair the accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction, where areas of calcification identified on a non-contrast scan are removed from the contrast enhanced images.

  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:   55 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age over 55 years
    2. Subjects referred for coronary angiography
    3. Able to understand and willing to sign the Informed Consent Form

EXCLUSION CRITERIA:

  1. Known allergy to iodinated contrast media
  2. Estimated GFR less than 50 ml/min
  3. Atrial fibrillation or other continuous cardiac arrhythmias
  4. Known or suspected intolerance or contraindication to beta-blocker medication (i.e. significant reactive airway disease, decompensated heart failure, Mobitz type 2 second degree or 3rd degree atrio-ventricular heart block)
  5. Inability to adequately hold breath for 5 seconds
  6. Pregnancy. Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study MDCT.
  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): NCT02303067


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
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
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:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02303067     History of Changes
Other Study ID Numbers: 150026
15-H-0026
First Submitted: November 25, 2014
First Posted: November 27, 2014
Last Update Posted: October 19, 2017
Last Verified: September 14, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Cardiac
Computed Tomography
Coronary Artery Disease

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