Validation of Coronary Calcium Subtraction to Improve Diagnostic Accuracy of Coronary CT Angiography

NCT02011061 | Completed

• 2 other identifiers: H-3-2013-108ZIAHL006138
• Study Type: observational
• Target: 182
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Multidetector Computed Tomography; Coronary Stenosis; Coronary Artery Disease; Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of Coronary Subtraction Coronary CT angiography

  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.

  Within 90 days of ICA and CCTA

Secondary Outcomes (3)

• Coronary CT angiography reader confidence

  Within 90 days of ICA and CCTA

• Coronary stenosis severity in non-diagnostic or partially diagnostic segments by conventional CCTA

  Within 90 days of ICA and CCTA

• Coronary revascularization

  Within 30 days after CCTA

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

National Heart, Lung and Blood Institute

Bethesda, Maryland, 20892, United States

Location

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (3)

• Abdulla J, Pedersen KS, Budoff M, Kofoed KF. Influence of coronary calcification on the diagnostic accuracy of 64-slice computed tomography coronary angiography: a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2012 Apr;28(4):943-53. doi: 10.1007/s10554-011-9902-6. Epub 2011 Jun 12.

  PMID: 21667273 BACKGROUND

• Tanaka R, Yoshioka K, Muranaka K, Chiba T, Ueda T, Sasaki T, Fusazaki T, Ehara S. Improved evaluation of calcified segments on coronary CT angiography: a feasibility study of coronary calcium subtraction. Int J Cardiovasc Imaging. 2013 Dec;29 Suppl 2:75-81. doi: 10.1007/s10554-013-0316-5. Epub 2013 Oct 25.

  PMID: 24158235 BACKGROUND

• Fuchs A, Kuhl JT, Chen MY, Helqvist S, Razeto M, Arakita K, Steveson C, Arai AE, Kofoed KF. Feasibility of coronary calcium and stent image subtraction using 320-detector row CT angiography. J Cardiovasc Comput Tomogr. 2015 Sep-Oct;9(5):393-8. doi: 10.1016/j.jcct.2015.03.016. Epub 2015 Apr 16.

  PMID: 26091841 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus F Kofoed, MD, DmSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 13, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

DK (1); US (1)