Coronary SyndromeEVASCANNCT00709709
Medical Evaluation of Scanner in Coronary Syndrome
A study testing multislice coronary scan in people with Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Syndrome
- What is being tested?
- multislice coronary scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Dec 2008
- 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' ≥18 years, of both sexes
- Coronary angiography in patients with suspected of known CAD, instable clinical conditions.
- Clinical status allowing performance of coronary angiography 48 à 72h after CT examination
- Informed consent signed by patient
Who cannot join
- Patients in whom clinical status does not allow delayed coronary angiography
- Irregular heart rate, in particular atrial fibrillation
- Renal insufficiency (serum creatinine >150 µmol/l
- Radiology examination with use of iodin agent with 48h before) CT coronary
- K now intolerance to iodin agents
- Patients unable to hold breathing < 20 seconds
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography
Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis.
These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.
Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.
Read the detailed description
These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.
Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.
- Conditions
- Coronary Syndrome
- Being tested
- multislice coronary scan
- Keywords
- stenosis, coronaropathy, stent, bypass surgery, suspect, known
- Medical subject headings
- Angina, Unstable, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multislice coronary scanProcedure or surgery
multislice coronary scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Scan Receives: Procedure: multislice coronary scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensibility of scanner
Measured: visit 1
Secondary outcomes (1)
Quality of coronary scanner imaging
Measured: visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Gueret, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709709
- Sponsor's protocol ID
- P060105
- Acronym
- EVASCAN
- Status last verified
- Jul 2008
- First submitted
- 2 Jul 2008
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography
- ClinicalTrials.gov ID
- NCT00709709
- Acronym / sponsor ID
- EVASCAN / P060105
- Conditions
- Coronary Syndrome
- Keywords
- stenosis, coronaropathy, stent, bypass surgery, suspect, known
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 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.
Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis.
These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.
Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.
Detailed description
These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.
Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: multislice coronary scanScan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients' ≥18 years, of both sexes
- Coronary angiography in patients with suspected of known CAD, instable clinical conditions.
- Clinical status allowing performance of coronary angiography 48 à 72h after CT examination
- Informed consent signed by patient
Key exclusion criteria (7 listed)
- Patients in whom clinical status does not allow delayed coronary angiography
- Irregular heart rate, in particular atrial fibrillation
- Renal insufficiency (serum creatinine >150 µmol/l
- Radiology examination with use of iodin agent with 48h before) CT coronary
- K now intolerance to iodin agents
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 |
|---|---|---|
| multislice coronary scanmultislice coronary scan | Procedure or surgery | 1 |
Primary outcome
Specificity and sensibility of scanner
Time frame: visit 1
1 secondary outcome
Quality of coronary scanner imaging
Time frame: visit 1
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 14 Nov 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.
Pascal Gueret, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multislice coronary scan in people with Coronary Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 4 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 14 Nov 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?
Specificity and sensibility of scanner (time frame: visit 1). 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 14 Nov 2014.