High Definition CT Coronary Angiography Accuracy Trial

Coronary Artery Disease Clinical Trial

Official title:

Diagnostic Performance of 64 Slice High Definition Computed Tomographic Coronary Angiography in Patients With High Risk of Significant Coronary Artery Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946737
• Other study ID #: 11/P/050
• Secondary ID: 11/H0206/5
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: September 16, 2013
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: September 2013
• Source: Plymouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients > 40 years of age.

• Suspected or known coronary artery disease

• Admitted for diagnostic ICA

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

• Active Comparator: Invasive coronary angiography (ICA)

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The radiation dose delivered by HD-CTCA		4 weeks	Yes
Primary	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	No
Secondary	The diagnostic accuracy of HD-CTCA for the detection of severe stenosis (70%) as defined by invasive coronary angiography.		4 weeks	No