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Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography (C-Sub320)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Klaus Fuglsang Kofoed, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02011061
First received: December 2, 2013
Last updated: November 4, 2014
Last verified: November 2014
History of Changes
  Purpose

Coronary calcium hampers accurate evaluation of the coronary arteries with coronary computed tomography angiography (CCTA). A novel approach to potentially overcome this limitation is coronary calcium subtraction.

The primary hypothesis of the study is:

- Coronary calcium subtraction CCTA will improve diagnostic accuracy as compared to conventional CCTA on a per-patient basis


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective International Study of Coronary Substraction Using 320 Row-detector CT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Diagnostic accuracy of Coronary Subtraction Coronary CT angiography [ Time Frame: Within 90 days of ICA and CCTA ] [ Designated as safety issue: No ]
    Sensitivity, Specificity, Negative and Positive predictive value of Coronary Subtraction CT angiography by visual assessment to identify a >50% coronary stenosis as defined by invasive coronary angiography on a patient by patient level.


Secondary Outcome Measures:
  • Coronary CT angiography reader confidence [ Time Frame: Within 90 days of ICA and CCTA ] [ Designated as safety issue: No ]
    Coronary CT angiography reader confidence by a 3 level visual scale assessed on CT images without and with Coronary Calcium Subtraction

  • Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional CCTA [ Time Frame: Within 90 days of ICA and CCTA ] [ Designated as safety issue: No ]
    In coronary segments deemed non-diagnostic or partially diagnostic due to calcification or coronary stents by conventional CCTA concordance of stenosis severity by Coronary Subtraction CT angiography and invasive quantitative coronary angiography is assessed

  • Coronary revascularization [ Time Frame: Within 30 days after CCTA ] [ Designated as safety issue: No ]
    On a patient by patient level the ability of CCTA to predict need for coronary revascularization (PCI or CABG) is assessed using CCTA without and with coronary calcium subtraction
Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Detailed Description:

CCTA is a very important clinical method for the clinical evaluation of patients with chest pain of potential cardiac ischemic origin. However Coronary calcification and/or previously implanted coronary stents may limit the diagnostic accuracy of CCTA. A novel approach - coronary calcium subtraction - has been developed to potentially overcome this limitation.

  • Study Objective: To assess diagnostic accuracy using coronary calcium subtraction coronary CT angiography (CCTA) as compared to conventional CCTA.
  • Material and Methods: A total of 200 patients with suspected or known coronary artery disease (CAD) who have been referred for invasive coronary angiography (ICA) will prior to ICA undergo additional research CCTA with the newly developed coronary calcium subtraction protocol. Based on the coronary calcium scan (CS), coronary calcium score will be calculated according to the Agatston score. Conventional contrast enhanced CCTA studies will be analyzed for image quality and the presence and extent of coronary stenosis. Using a dedicated algorithm, subtraction will be performed on all datasets to obtain CCTA subtraction images. Subtracted images will be analyzed similar to the conventional CCTA images. ICA will serve as the gold standard. Image quality will be compared between conventional and subtracted CCTA. In addition, diagnostic accuracy in the evaluation of coronary stenosis as determined on ICA will be compared. Finally, factors influencing the performance of coronary calcium subtraction will be evaluated.
  Eligibility
Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients (N=200) referred for in hospital invasive coronary evaluation

Criteria

Inclusion Criteria:

  • Age > 55 Years
  • Scheduled for invasive coronary angiography
  • Logistically possible to perform CCTA before invasive evaluation

Exclusion Criteria:

  • Known Iodine-contrast allergy
  • Estimated GFR below 50 ml/min
  • Atrial fibrillation or other persistence cardiac arrythmia
  • Contraindication to betablockers (bronchospasm, LVEF less than 40%)
  • Implanted PM or ICD
  • Previous mechanical heart valve surgery
  • Inability to maintain breath-hold for at least 5 sec
  • Patient-related condition resulting the inability of the patient to understand the informed consent form of the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011061

Contacts
Contact: Klaus F Kofoed, MD, DmSc +45 35458569 kkofoed@dadlnet.dk

Locations
United States, Maryland
National Heart, Lung and Blood Institute Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: Marsha Block, RN    301-496-0211    blockma@mail.nih.gov   
Principal Investigator: Marcus Chen, MD         
Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Klaus F Kofoed, MD, DmSc    +45 35458569    kkofoed@dadlnet.dk   
Sub-Investigator: Andreas Fuchs, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Klaus F Kofoed, MD, DmSc Rigshospitalet, University of Copenhagen, Denmark
  More Information

Additional Information:
Clinical Research Unit, Department of Cardiology, Rigshospitalet  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Klaus Fuglsang Kofoed, associate professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02011061     History of Changes
Other Study ID Numbers: H-3-2013-108, ZIAHL006138
Study First Received: December 2, 2013
Last Updated: November 4, 2014
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Multidetector Computed Tomography
Coronary Stenosis
Coronary Artery Disease
Angina Pectoris

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

ClinicalTrials.gov processed this record on March 02, 2015