Comparing Angiography: Multislice CT Versus Invasive Heart Catheterization

Status Completed

Clinical Trial Summary

The purpose of the study is to compare the pictures of heart arteries obtained by MSCT scanner to the pictures obtained during heart catheterization. Our specific question is whether the MSCT scanner is accurate enough to replace heart catheterization in some situations for the evaluation of coronary heart disease.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00284466
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Completed
Phase	N/A
Start date	January 2006
Completion date	August 2006

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparing Angiography: Multislice CT Versus Invasive Heart Catheterization (CACTI)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms