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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
Sponsor:
Information provided by:
Rennes University Hospital

Tracking Information
First Submitted Date  ICMJE March 21, 2006
First Posted Date  ICMJE March 22, 2006
Last Update Posted Date February 26, 2008
Study Start Date  ICMJE February 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2008)
  • Detection of > 50% coronary stenosis [ Time Frame: During assessment ]
  • Sensibility, specificity, positive and negative predictive values of MSCT [ Time Frame: During assessment ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2006)
  • Detection of > 50% coronary stenosis
  • Sensibility, specificity, positive and negative predictive values of MSCT
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2006)
  • - Detection of patients with one or more coronary stenosis
  • - Detection of patients with 3-vessel disease
  • - Left ventricle telediastolic diameter
  • - Septal telediastolic thickness
  • - Posterior wall telediastolic thickness
  • - Detection of coronary sinus branches
  • - Measurement of coronary sinus branches diameter
  • - Assessment of renal function 7 days after MSCT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multislice Spiral Computed Tomography and Cardiomyopathy
Official Title  ICMJE Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cardiomyopathies
Intervention  ICMJE
  • Procedure: Multislice spiral computed tomography coronary angiography
    Other Name: MSCT
  • Procedure: conventional coronary angiography
Study Arms  ICMJE
  • Active Comparator: 1
    conventional coronary angiography
    Intervention: Procedure: conventional coronary angiography
  • Experimental: 2
    multislice spiral computed tomography coronary angiography
    Intervention: Procedure: Multislice spiral computed tomography coronary angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2008)
60
Original Enrollment  ICMJE
 (submitted: March 21, 2006)
120
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00305916
Other Study ID Numbers  ICMJE AFSSAPS 2005/06/004
CIC0203/045
LOC/04-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Direction of Clinical Research and Strategy, Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominique Boulmier, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
Study Chair: David Veillard, MD Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP