Multislice Spiral Computed Tomography and Cardiomyopathy (CMD-scanner)
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ClinicalTrials.gov Identifier: NCT00305916 |
Recruitment Status :
Completed
First Posted : March 22, 2006
Last Update Posted : February 26, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiomyopathies | Procedure: Multislice spiral computed tomography coronary angiography Procedure: conventional coronary angiography | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study"). |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
conventional coronary angiography
|
Procedure: conventional coronary angiography |
Experimental: 2
multislice spiral computed tomography coronary angiography
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Procedure: Multislice spiral computed tomography coronary angiography
Other Name: MSCT |
- Detection of > 50% coronary stenosis [ Time Frame: During assessment ]
- Sensibility, specificity, positive and negative predictive values of MSCT [ Time Frame: During assessment ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305916
France | |
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou | |
Rennes, France, 35033 |
Principal Investigator: | Dominique Boulmier, MD | Rennes University Hospital | |
Study Chair: | Bruno Laviolle, MD | Rennes University Hospital | |
Study Chair: | David Veillard, MD | Rennes University Hospital |
Responsible Party: | Direction of Clinical Research and Strategy, Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT00305916 |
Other Study ID Numbers: |
AFSSAPS 2005/06/004 CIC0203/045 LOC/04-05 |
First Posted: | March 22, 2006 Key Record Dates |
Last Update Posted: | February 26, 2008 |
Last Verified: | February 2008 |
MSCT Idiopathic Cardiomyopathy Sinus rhythm |
Cardiomyopathies Heart Diseases Cardiovascular Diseases |