Coronary Artery DiseasePhase 3NCT00846079
Myocardial Perfusion Assessment With Multidetector Computed Tomography
A Phase 3 study testing Regadenoson (Lexiscan) [muti-detector computed tomography] in people with Coronary Artery Disease, run by Tennessee Heart and Vascular Institute, P.C. at 1 site in United States.
Trial summary
Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Regadenoson (Lexiscan) [muti-detector computed tomography]
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2009
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- Adults undergoing myocardial perfusion SPECT imaging
- Adults with suspected coronary artery disease
Who cannot join
- Age <18
- Known or suspected renal insufficiency (Creatinine <1.7 mg/dl)
- Allergy to contrast
- Inability or contraindication to lexiscan or beta blocker
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Heart and Vascular Institute
Hendersonville, Tennessee
About this study
Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.
- Conditions
- Coronary Artery Disease
- Being tested
- Regadenoson (Lexiscan) [muti-detector computed tomography]
- Keywords
- coronary artery disease, stress testing
- 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.
Regadenoson (Lexiscan) [muti-detector computed tomography]Device
Also called Lexiscan
Regadenason, typical dosing
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
Measured: 6 months
Secondary outcomes (1)
Radiation dosimetry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tennessee Heart and Vascular Institute, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846079
- Sponsor's protocol ID
- THVI-101
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Assessment With Multidetector Computed Tomography
- ClinicalTrials.gov ID
- NCT00846079
- Acronym / sponsor ID
- THVI-101
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, stress testing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tennessee Heart and Vascular Institute, P.C.University, hospital or other
- Collaborators
- General Electric
- Study start
- Feb 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 18 Feb 2009 (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.
Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults >18 years of age
- Adults undergoing myocardial perfusion SPECT imaging
- Adults with suspected coronary artery disease
Key exclusion criteria (4 listed)
- Age <18
- Known or suspected renal insufficiency (Creatinine <1.7 mg/dl)
- Allergy to contrast
- Inability or contraindication to lexiscan or beta blocker
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 |
|---|---|---|
| Regadenoson (Lexiscan) [muti-detector computed tomography]Also: LexiscanRegadenason, typical dosing | Device | – |
Primary outcome
Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value)
Time frame: 6 months
1 secondary outcome
Radiation dosimetry
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regadenoson (Lexiscan) [muti-detector computed tomography] in people with Coronary Artery Disease, run by Tennessee Heart and Vascular Institute, P.C. 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Feb 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value) (time frame: 6 months). 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 18 Feb 2009.