Comparing Angiography: Multislice CT Versus Invasive Heart Catheterization (CACTI)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Comparing Angiography: Multislice CT vs. Invasive Heart Catheterization (CACTI)|
- The primary endpoint of the study is the ability of CTA to detect coronary disease of greater than 50% diameter stenosis (sensitivity, specificity, positive and negative predictive value) analyzed on a subject basis. [ Time Frame: assess at time of CTA ] [ Designated as safety issue: No ]
- Assess CTA performance on both a vessel and coronary segment basis [ Time Frame: assessed at time of CTA ] [ Designated as safety issue: No ]
- Estimate the impact of coronary calcium score on ability to assess for coronary disease [ Time Frame: assessed at time of CTA ] [ Designated as safety issue: No ]
- Evaluate impact of scan quality of CTA performance measures [ Time Frame: assessed at time of CTA ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Procedure: MS-CT Coronary Angiography
QUESTION: Compare the accuracy of multi-slice CT angiography (CTA) with invasive catheterization (Cath) in detecting and grading coronary lesions.
EXPERIMENTAL DESIGN: A prospective cohort analysis comparing the quantification of coronary atherosclerosis by Computed Tomographic angiography to that of invasive Catheterization. Subjects will be patients who are scheduled for non-urgent cardiac cath based on a clinical need to evaluate the coronary anatomy. Cath may be scheduled after a positive stress test or on the basis of concerning symptoms. If a patient consents to participation they will be scheduled for CTA no less than 3 and no more than 30 days prior to Cath. Comparison of lesions detected by the two imaging modalities in the proximal, mid and distal coronary arteries will be made. Grades of disease used will be the following 1). less than 50% 2). 50-75% 3). greater than 75% 4) Uninterpretable. Sensitivity and specificity will be calculated for CTA; in addition PPV and NPV will also be calculated. The 2 readers of the CTA will be blinded to the invasive angiography results. The 2 readers of the invasive angiography, who are blinded to the CTA results will be the standard of comparison. Analysis of data will be performed on a segmental, vessel, and patient basis.
POTENTIAL RISK: Risks associated with contrast exposure include the risk of allergic reaction and renal injury. There is a small risk of excessive bradycardia and hypotension with administration of metoprolol and nitroglycerine. CTA is associated with radiation exposure similar to the lower range of diagnostic catheterization.
POTENTIAL BENEFITS: No direct benefits are expected for the subjects of this study as the information will not be used to alter clinical decisions. Benefits to future patients may include the development of an non-invasive alternative to cardiac catheterization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284466
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Jon G Keevil, MD||University of Wisconsin, Madison|