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High Definition CT Coronary Angiography Accuracy Trial

NCT01946737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2013-09-20

No results posted yet for this study

Summary

CT technology is evolving at a rapid pace, with introduction of multidetector row CT scanners (MDCT) and electrocardiographic (ECG) gating resulting in increasing numbers of heart scans CTCA (CT Coronary Angiography). CTCA provides a noninvasive alternative to conventional invasive coronary angiography (ICA), which is considered the gold standard in the investigation of coronary disease. There has been a gradual increase in the utilization of CTCA for primary assessment of low and intermediate risk patients. However concerns regarding radiation exposure and diagnostic accuracy, especially in the highrisk group, have prevented its widespread dissemination.

To achieve best possible temporal resolution (minimize cardiac motion artifacts) and spatial resolution (provide diagnostic accuracy) relatively high radiation exposure is required, as a result of its inverse relationship with image noise and resolution. However radiation (X-ray) is associated with increased risk of cancer in exposed patients and it is therefore essential to continually devise strategies to reduce radiation exposure whilst maintaining image quality.

A state-of-art CT scanner (Discovery CT750 HD, General Electric (GE) Healthcare), has been installed at Derriford hospital for further research on CTCA. It uses novel method of scanning, High Definition Computed Tomographic Coronary Angiography(HD-CTCA), analogous to high definition television) and image reconstruction (Adaptive Statistical Iterative Reconstruction ASIR)as opposed to conventional CT scanners using Filtered Back Projection (FBP)reconstruction. HD-CTCA enables acquisition of sharper images and ASIR offsets the resultant increase in radiation exposure. This is likely to result in images of higher diagnostic quality with an equivalent or slightly lower radiation exposure compared to present technology. Although initial results are encouraging, this needs further assessment before being applied to routine clinical practice. To assess this we have designed a study to perform HD-CTCA on 300 consecutive patients undergoing diagnostic ICA at Derriford hospital, directly comparing the accuracy of HD-CTCA to ICA (presently considered the gold standard).

Hypotheses:

There is no significant difference in the sensitivity and specificity of HD-CTCA for the detection of coronary artery stenosis of 50% or greater compared to conventional ICA.

Conditions

  • Coronary Artery Disease

Interventions

RADIATION

HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)

RADIATION

Active Comparator: Invasive coronary angiography (ICA)

Sponsors & Collaborators

  • University Hospital Plymouth NHS Trust

    lead OTHER

Principal Investigators

  • Carl Roobottom, BSc, MBChB(hon), MRCP. FRCR · University Hospital Plymouth NHS Trust

  • Srikanth Iyengar, MBBS, MS, FRCS, FRCR · University Hospital Plymouth NHS Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01946737 on ClinicalTrials.gov