Comparing Angiography: Multislice CT Versus Invasive Heart Catheterization (CACTI)
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 27, 2006
CompletedFirst Posted
Study publicly available on registry
January 31, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedAugust 29, 2012
August 1, 2012
7 months
January 27, 2006
August 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Assess CTA performance on both a vessel and coronary segment basis
assessed at time of CTA
Estimate the impact of coronary calcium score on ability to assess for coronary disease
assessed at time of CTA
Evaluate impact of scan quality of CTA performance measures
assessed at time of CTA
Interventions
MS-CT Coronary Angiography done
Eligibility Criteria
You may qualify if:
- Subjects \>18 years old with stable clinical symptoms who are scheduled for outpatient cardiac catheterization.
- Able to provide written informed consent in accordance with the IRB.
You may not qualify if:
- Symptoms of unstable angina/acute coronary syndrome
- Known allergy or adverse reaction to CT radiocontrast and/or iodine.
- Known absolute contraindication to Metoprolol.
- Significant kidney disease including creatinine \> 1.5 mg/dL or GFR \< 60 ml/min.
- Inability to breath-hold for up to 30 seconds.
- Women who are Pregnant or Nursing
- Atrial Fibrillation or any other arrhythmia that makes attaining a regular slow rhythm unlikely.
- History of previous stent placement or coronary bypass surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon G Keevil, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2006
First Posted
January 31, 2006
Study Start
January 1, 2006
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
August 29, 2012
Record last verified: 2012-08