Coronary ArteriosclerosisNCT00284466
Comparing Angiography: Multislice CT Versus Invasive Heart Catheterization (CACTI)
A study testing MS-CT Coronary Angiography in people with Coronary Arteriosclerosis, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- What is being tested?
- MS-CT Coronary Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Angiography: Multislice CT vs. Invasive Heart Catheterization (CACTI)
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.
Read the 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.
- Conditions
- Coronary Arteriosclerosis
- Being tested
- MS-CT Coronary Angiography
- Keywords
- coronary artery disease, cardiac catheterization, CT coronary angiography, coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-CT Coronary AngiographyProcedure or surgery
MS-CT Coronary Angiography done
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assess at time of CTA
Secondary outcomes (3)
Assess CTA performance on both a vessel and coronary segment basis
Measured: assessed at time of CTA
Estimate the impact of coronary calcium score on ability to assess for coronary disease
Measured: assessed at time of CTA
Evaluate impact of scan quality of CTA performance measures
Measured: assessed at time of CTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon G Keevil, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284466
- Sponsor's protocol ID
- HS-IRB 2005-0377
- Status last verified
- Aug 2012
- First submitted
- 27 Jan 2006
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Angiography: Multislice CT vs. Invasive Heart Catheterization (CACTI)
- ClinicalTrials.gov ID
- NCT00284466
- Acronym / sponsor ID
- HS-IRB 2005-0377
- Conditions
- Coronary Arteriosclerosis
- Keywords
- coronary artery disease, cardiac catheterization, CT coronary angiography, coronary angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-CT Coronary AngiographyMS-CT Coronary Angiography done | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
Assess CTA performance on both a vessel and coronary segment basis
Time frame: assessed at time of CTA
Estimate the impact of coronary calcium score on ability to assess for coronary disease
Time frame: assessed at time of CTA
Evaluate impact of scan quality of CTA performance measures
Time frame: assessed at time of CTA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon G Keevil, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS-CT Coronary Angiography in people with Coronary Arteriosclerosis, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.