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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00284466
First received: January 27, 2006
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Coronary Arteriosclerosis
Procedure: MS-CT Coronary Angiography

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: January 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: MS-CT Coronary Angiography
    MS-CT Coronary Angiography done
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284466

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Jon G Keevil, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00284466     History of Changes
Other Study ID Numbers: HS-IRB 2005-0377
Study First Received: January 27, 2006
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
coronary artery disease
cardiac catheterization
CT coronary angiography
coronary angiography

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on September 22, 2014