Clinical Trial: Multislice Spiral Computed Tomography and Cardiomyopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Rennes University Hospital

Current Primary Outcome:

  • 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:

  • Detection of > 50% coronary stenosis
  • Sensibility, specificity, positive and negative predictive values of MSCT


Current Secondary Outcome:

  • 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:

  • - 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


Information By: Rennes University Hospital

Dates:
Date Received: March 21, 2006
Date Started: February 2006
Date Completion:
Last Updated: February 22, 2008
Last Verified: February 2008