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

Coronary Arteriosclerosis Clinical Trial

Official title:

Comparing Angiography: Multislice CT vs. Invasive Heart Catheterization (CACTI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284466
• Other study ID #: HS-IRB 2005-0377
• Status: Completed
• Phase: N/A
• First received: January 27, 2006
• Last updated: August 28, 2012
• Start date: January 2006
• Est. completion date: August 2006

Study information

• Verified date: August 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects >18 years old with stable clinical symptoms who are scheduled for outpatient cardiac catheterization.

2. Able to provide written informed consent in accordance with the IRB.

Exclusion Criteria:

1. Symptoms of unstable angina/acute coronary syndrome

2. Known allergy or adverse reaction to CT radiocontrast and/or iodine.

3. Known absolute contraindication to Metoprolol.

4. Significant kidney disease including creatinine > 1.5 mg/dL or GFR < 60 ml/min.

5. Inability to breath-hold for up to 30 seconds.

6. Women who are Pregnant or Nursing

7. Atrial Fibrillation or any other arrhythmia that makes attaining a regular slow rhythm unlikely.

8. History of previous stent placement or coronary bypass surgery.

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

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Procedure:
• MS-CT Coronary Angiography
MS-CT Coronary Angiography done

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		assess at time of CTA	No
Secondary	Assess CTA performance on both a vessel and coronary segment basis		assessed at time of CTA	No
Secondary	Estimate the impact of coronary calcium score on ability to assess for coronary disease		assessed at time of CTA	No
Secondary	Evaluate impact of scan quality of CTA performance measures		assessed at time of CTA	No