CardiomyopathiesCMD-scannerNCT00305916
Multislice Spiral Computed Tomography and Cardiomyopathy
A study testing Multislice spiral computed tomography coronary angiography and conventional coronary angiography in people with Cardiomyopathies, run by Rennes University Hospital at 1 site in France.
Trial summary
Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Multislice spiral computed tomography coronary angiography and conventional coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Feb 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 scheduled to undergo coronary angiography,
- etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease),
- in sinus rhythm,
- informed written consent.
Who cannot join
- allergy to iodine,
- history of coronary artery bypass graft,
- history of percutaneous coronary angioplasty,
- history of myocardial infarction,
- known coronary artery disease,
- Q waves on the ECG,
Show all 12Show fewer
- unstable haemodynamic status,
- urgent revascularisation or urgent valvular surgery,
- heart rate > 80 bpm (before MSCT),
- pregnancy,
- enrollment in another study.
- severe renal or respiratory insufficiency.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou
Rennes, 35033
About this study
Official title: Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").
Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary angiography.
Read the detailed description
The principal aim of this study is to assess the diagnostic accuracy (sensitivity, specificity, predictive values) of multislice spiral computed tomography (MSCT) coronary angiography among patients having idiopathic hypokinetic dilated cardiomyopathy in sinus rhythm, compared to conventional coronary angiography. The secondary aims are to assess the performance of MSCT in coronary sinus anatomy assessment, and in quantitative measurement of left ventricular anatomical criteria (telediastolic diameter, septal and posterior wall thickness, and ejection fraction) compared to echocardiography. Lastly, renal tolerance of MSCT will be studied. This prospective monocentric study will include 120 patients scheduled to undergo coronary angiography for etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease) in sinus rhythm. MSCT will be performed within 3 months after conventional coronary angiography, with blinded analysis.
- Conditions
- Cardiomyopathies
- Being tested
- Multislice spiral computed tomography coronary angiography, conventional coronary angiography
- Keywords
- MSCT, Idiopathic Cardiomyopathy, Sinus rhythm
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multislice spiral computed tomography coronary angiographyProcedure or surgery
Also called MSCT
conventional coronary angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | conventional coronary angiography Receives: Procedure: conventional coronary angiography |
| 2 | Experimental | multislice spiral computed tomography coronary angiography Receives: Procedure: Multislice spiral computed tomography coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of > 50% coronary stenosis
Measured: During assessment
Sensibility, specificity, positive and negative predictive values of MSCT
Measured: During assessment
Secondary outcomes (8)
Detection of patients with one or more coronary stenosis
Measured: During assessment
Detection of patients with 3-vessel disease
Measured: During assessment
Left ventricle telediastolic diameter
Measured: During assessment
Septal telediastolic thickness
Measured: During assessment
Posterior wall telediastolic thickness
Measured: During assessment
Detection of coronary sinus branches
Measured: During assessment
Measurement of coronary sinus branches diameter
Measured: During assessment
Assessment of renal function 7 days after MSCT
Measured: During assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dominique Boulmier, MD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University HospitalDavid Veillard, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305916
- Sponsor's protocol ID
- AFSSAPS 2005/06/004
- Other IDs
- CIC0203/045, LOC/04-05
- Acronym
- CMD-scanner
- Status last verified
- Feb 2008
- First submitted
- 21 Mar 2006
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").
- ClinicalTrials.gov ID
- NCT00305916
- Acronym / sponsor ID
- CMD-scanner / AFSSAPS 2005/06/004
- Conditions
- Cardiomyopathies
- Keywords
- MSCT, Idiopathic Cardiomyopathy, Sinus rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Mar 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.
Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary angiography.
Detailed description
The principal aim of this study is to assess the diagnostic accuracy (sensitivity, specificity, predictive values) of multislice spiral computed tomography (MSCT) coronary angiography among patients having idiopathic hypokinetic dilated cardiomyopathy in sinus rhythm, compared to conventional coronary angiography. The secondary aims are to assess the performance of MSCT in coronary sinus anatomy assessment, and in quantitative measurement of left ventricular anatomical criteria (telediastolic diameter, septal and posterior wall thickness, and ejection fraction) compared to echocardiography. Lastly, renal tolerance of MSCT will be studied. This prospective monocentric study will include 120 patients scheduled to undergo coronary angiography for etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease) in sinus rhythm. MSCT will be performed within 3 months after conventional coronary angiography, with blinded analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: conventional coronary angiographyconventional coronary angiography |
| 2 | Experimental | Procedure: Multislice spiral computed tomography coronary angiographymultislice spiral computed tomography coronary angiography |
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 scheduled to undergo coronary angiography,
- etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease),
- in sinus rhythm,
- informed written consent.
Key exclusion criteria (12 listed)
- allergy to iodine,
- history of coronary artery bypass graft,
- history of percutaneous coronary angioplasty,
- history of myocardial infarction,
- known coronary artery disease,
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 spiral computed tomography coronary angiographyAlso: MSCT | Procedure or surgery | 2 |
| conventional coronary angiography | Procedure or surgery | 1 |
Primary outcome
Detection of > 50% coronary stenosis
Time frame: During assessment
Sensibility, specificity, positive and negative predictive values of MSCT
Time frame: During assessment
8 secondary outcomes
Detection of patients with one or more coronary stenosis
Time frame: During assessment
Detection of patients with 3-vessel disease
Time frame: During assessment
Left ventricle telediastolic diameter
Time frame: During assessment
Septal telediastolic thickness
Time frame: During assessment
Posterior wall telediastolic thickness
Time frame: During assessment
Detection of coronary sinus branches
Time frame: During assessment
Measurement of coronary sinus branches diameter
Time frame: During assessment
Assessment of renal function 7 days after MSCT
Time frame: During assessment
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 26 Feb 2008.
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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.
Dominique Boulmier, MD principal investigator
Rennes University Hospital
Bruno Laviolle, MD study chair
Rennes University Hospital
David Veillard, MD study chair
Rennes University Hospital
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 spiral computed tomography coronary angiography and conventional coronary angiography in people with Cardiomyopathies, run by Rennes University Hospital 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 12 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 26 Feb 2008. 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?
Detection of > 50% coronary stenosis (time frame: During assessment). The study lists 2 primary outcomes in all. 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 26 Feb 2008.