Coronary Artery LesionNCT00949520
Stress Multidetector Computed Tomography (MDCT) an New Diagnostic Tool for Myocardial Disease
A study testing coronary dual source computed tomography (DSCT) and myocardial single photon emission computed topography (SPECT) in people with Coronary Artery Lesion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial ischemia. There is some preliminary data in the literature showing the ability of MDCT under stress to bring relevant information about myocardial ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Lesion
- What is being tested?
- coronary dual source computed tomography (DSCT) and myocardial single photon emission computed topography (SPECT)
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Nov 2011
- 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
- Patients who required functional evaluation of a known coronary artery lesion
Who cannot join
- Disorders of the heart rhythm
- Myocardial infarct dating less than a month
- Unstable anger
- Congestive heart failure stages 3 and 4 of NYHA
- Renal failure
- Pregnancy and feeding
- History of anaphylactic reaction in the injection of iodized product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Source Computed Tomography (DSCT) During Injection of Dipyridamole : a New Technique for Myocardial Ischemia Assessment
The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial ischemia. There is some preliminary data in the literature showing the ability of MDCT under stress to bring relevant information about myocardial ischemia. Stress MDCT will have several advantages over single photon emission computed tomography (SPECT) imaging namely: shorter acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is still debated and need to be address in a clinical study.
Read the detailed description
Hypothesis: Cardiac dual source computed tomography (DSCT) performed during dipyridamole infusion allows for 1) myocardial perfusion analysis and detection of myocardial ischemia and 2) good quality evaluation (artefact free) of the coronary artery anatomy. Cardiac DSCT during dipyridamole infusion may assess in a single volume acquisition relevant information about coronary anatomy and myocardial ischemia that required today two different examinations each with a cost and side effects. Recently investigators showed on animal models as well as in humans that MDCT during stress test could detect myocardial ischemia.
Purposes: 1) To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference. 2) To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.
Methods: This prospective study will include patients referred from the department of cardiology of Nord hospital. Inclusion criteria will be: patients who required functional evaluation of a known coronary artery lesion. Patients will be successively include. Each patient will undergo myocardial SPECT and coronary DSCT during dipyridamole injection. Coronary DSCT image analysis will determine the severity and the extension of the ischemic territory. Statistical analysis will determine the reproductibility of the described technique, compared the DSCT with SPECT as standard of reference and determined sensitivity, specificity and predictive values (positive and negative) of the described technique.
- Conditions
- Coronary Artery Lesion
- Being tested
- coronary dual source computed tomography (DSCT), myocardial single photon emission computed topography (SPECT)
- Keywords
- patients, functional evaluation, known coronary artery lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary dual source computed tomography (DSCT)Other
Also called coronary DSCT
coronary dual source computed tomography during dipyridamole injection
myocardial single photon emission computed topography (SPECT)Other
Also called myocardial SPECT
myocardial single photon emission computed topography during dipyridamole injection
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference.
Measured: 1 year
Secondary outcomes (1)
To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery LesionStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Jacquier, Principal investigator, Assistance Publique-Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949520
- Sponsor's protocol ID
- 2009/12
- Other IDs
- 2009-A00364-53
- Status last verified
- Feb 2014
- First submitted
- 29 Jul 2009
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Source Computed Tomography (DSCT) During Injection of Dipyridamole : a New Technique for Myocardial Ischemia Assessment
- ClinicalTrials.gov ID
- NCT00949520
- Acronym / sponsor ID
- 2009/12
- Conditions
- Coronary Artery Lesion
- Keywords
- patients, functional evaluation, known coronary artery lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2011 (actual)
- First posted
- 30 Jul 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.
The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial ischemia. There is some preliminary data in the literature showing the ability of MDCT under stress to bring relevant information about myocardial ischemia. Stress MDCT will have several advantages over single photon emission computed tomography (SPECT) imaging namely: shorter acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is still debated and need to be address in a clinical study.
Detailed description
Hypothesis: Cardiac dual source computed tomography (DSCT) performed during dipyridamole infusion allows for 1) myocardial perfusion analysis and detection of myocardial ischemia and 2) good quality evaluation (artefact free) of the coronary artery anatomy. Cardiac DSCT during dipyridamole infusion may assess in a single volume acquisition relevant information about coronary anatomy and myocardial ischemia that required today two different examinations each with a cost and side effects. Recently investigators showed on animal models as well as in humans that MDCT during stress test could detect myocardial ischemia.
Purposes: 1) To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference. 2) To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.
Methods: This prospective study will include patients referred from the department of cardiology of Nord hospital. Inclusion criteria will be: patients who required functional evaluation of a known coronary artery lesion. Patients will be successively include. Each patient will undergo myocardial SPECT and coronary DSCT during dipyridamole injection. Coronary DSCT image analysis will determine the severity and the extension of the ischemic territory. Statistical analysis will determine the reproductibility of the described technique, compared the DSCT with SPECT as standard of reference and determined sensitivity, specificity and predictive values (positive and negative) of the described technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- 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 (1 listed)
- Patients who required functional evaluation of a known coronary artery lesion
Key exclusion criteria (7 listed)
- Disorders of the heart rhythm
- Myocardial infarct dating less than a month
- Unstable anger
- Congestive heart failure stages 3 and 4 of NYHA
- Renal failure
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 |
|---|---|---|
| coronary dual source computed tomography (DSCT)Also: coronary DSCTcoronary dual source computed tomography during dipyridamole injection | Other | – |
| myocardial single photon emission computed topography (SPECT)Also: myocardial SPECTmyocardial single photon emission computed topography during dipyridamole injection | Other | – |
Primary outcome
To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference.
Time frame: 1 year
1 secondary outcome
To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.
Time frame: 1 year
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 25 Feb 2014.
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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.
Alexis Jacquier principal investigator
Assistance Publique-Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary dual source computed tomography (DSCT) and myocardial single photon emission computed topography (SPECT) in people with Coronary Artery Lesion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 1 inclusion and 7 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 25 Feb 2014. 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 France. 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?
To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference. (time frame: 1 year). 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 25 Feb 2014.