Heart DiseasesNCT00722813
Cost Effectiveness and Utility of Computed Tomography Angiography (CTA) and Cardiac Cath
An observational study of Heart Diseases, run by University of Michigan at 1 site in United States.
Trial summary
This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Survey
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2012
- Phase
- Observational
- 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
Study population: Subjects who have had both CTA and Cardiac catherizations
Who may be able to join
- Subjects who have had both CTA and Coronary angiogram.
- 18 years old and older.
Who cannot join
- Under 18 years of age
- Memory Impairment:
- Stroke
- Traumatic brain Injury
- Dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
About this study
Official title: Cost Effectiveness and Utility of Coronary Artery Computed Tomography Angiography (CTA) in Screening for Coronary Artery Disease
This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease.
Read the detailed description
This is a single site study that will retrospectively and prospectively identify and enroll 100 subjects, both male and female, 18 years of age and older who undergo both coronary angiography and coronary artery computed tomography (CT), using the electronic radiology and cardiology databases. The purpose is to conduct a survey to assess their preference for either test to diagnose coronary artery disease. Subjects should be within six months of having the tests to avoid memory and recall problems.
- Conditions
- Heart Diseases
- Being tested
- Survey
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
To determine patient preference for the two tests CT angiography (CTA) and catheter coronary angiography (CCA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of CT and catheter angiography
Utility of CT and catheter angiography was compared within patients who had both tests performed.
Measured: Within 6 months of testing with CT and catheter angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startOct 2006
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aine Kelly, MD, University of Michigan
- Investigators
- Aine Kelly, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722813
- Sponsor's protocol ID
- HUM00003409
- Status last verified
- Nov 2013
- First submitted
- 24 Jul 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness and Utility of Coronary Artery Computed Tomography Angiography (CTA) in Screening for Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00722813
- Acronym / sponsor ID
- HUM00003409
- Conditions
- Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Jul 2008 (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.
This is a research study to determine patient preferences between two different diagnostic tests; a CT angiogram (CTA) and a catheter angiogram, both of which are used at the University to screen for and detect heart disease.
Detailed description
This is a single site study that will retrospectively and prospectively identify and enroll 100 subjects, both male and female, 18 years of age and older who undergo both coronary angiography and coronary artery computed tomography (CT), using the electronic radiology and cardiology databases. The purpose is to conduct a survey to assess their preference for either test to diagnose coronary artery disease. Subjects should be within six months of having the tests to avoid memory and recall problems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have had both CTA and Cardiac catherizations
Key inclusion criteria (2 listed)
- Subjects who have had both CTA and Coronary angiogram.
- 18 years old and older.
Key exclusion criteria (5 listed)
- Under 18 years of age
- Memory Impairment:
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 |
|---|---|---|
| SurveyTo determine patient preference for the two tests CT angiography (CTA) and catheter coronary angiography (CCA). | Other | – |
Primary outcome
Utility of CT and catheter angiography
Time frame: Within 6 months of testing with CT and catheter angiography
Utility of CT and catheter angiography was compared within patients who had both tests performed.
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 21 Nov 2013.
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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.
Aine Kelly, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by University of Michigan 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 5 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 21 Nov 2013. 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?
Utility of CT and catheter angiography (time frame: Within 6 months of testing with CT and catheter angiography). 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 21 Nov 2013.