High Definition CT Coronary Angiography Accuracy Trial

NCT01946737 | Completed

• 2 other identifiers: 11/P/05011/H0206/5
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Coronary; Artery; Disease; Diagnostic; Performance; Angiography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of HD-CTCA for the detection of at least moderate stenosis (>50%) as defined on invasive coronary angiography in the high-risk target population.

  We designed the New Generation Computed Tomographic Coronary Angiography (NG-CTCA) study to assess the diagnostic accuracy of high-definition CT with iterative reconstruction in an unselected population of patients suitable for CTCA with either a high pre-test probability of, or established coronary artery disease. Our hypothesis is that NGCT has a comparable diagnostic performance to invasive coronary angiography (ICA), using this as the reference standard

  4 weeks

Secondary Outcomes (1)

• The diagnostic accuracy of HD-CTCA for the detection of severe stenosis (70%) as defined by invasive coronary angiography.

  4 weeks

Other Outcomes (1)

• The radiation dose delivered by HD-CTCA

  4 weeks

Study Arms (2)

Invasive coronary angiography (ICA)

ACTIVE COMPARATOR

Routine diagnostic ICA

Radiation: Active Comparator: Invasive coronary angiography (ICA)

HD-CTCA with ASIR

EXPERIMENTAL

HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)within 4 weeks of routine diagnostic ICA

Radiation: HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)

Interventions

HD-CTCA with Adaptive statistical iterative reconstruction (ASIR) RADIATION

HD-CTCA with ASIR

Active Comparator: Invasive coronary angiography (ICA) RADIATION

Invasive coronary angiography (ICA)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 40 years of age.
• Suspected or known coronary artery disease
• Admitted for diagnostic ICA

You may not qualify if:

• Consent cannot be obtained
• Age \<40 years
• New York Heart Association (NYHA) Functional Classification - class III or IV heart failure
• Emergency imaging required (not enough time to consider the trial)
• Allergy to iodinated contrast or previous contrast induced nephropathy
• Intolerance to betablockers
• Uncontrolled rhythm disturbances (not suitable for CTCA)
• Serum Creatinine \>200 micro mol/L within two weeks prior to procedure or chronic renal failure on dialysis

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl Roobottom, BSc, MBChB(hon), MRCP. FRCR

  University Hospital Plymouth NHS Trust

  STUDY CHAIR

• Srikanth Iyengar, MBBS, MS, FRCS, FRCR

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 20, 2013
• Study Start: April 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

GB (1)