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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiomyopathies Procedure: Multislice spiral computed tomography coronary angiography Procedure: conventional coronary angiography Not Applicable

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
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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

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
conventional coronary angiography
 Procedure: conventional coronary angiography
Experimental: 2
multislice spiral computed tomography coronary angiography
 Procedure: Multislice spiral computed tomography coronary angiography
Other Name: MSCT


Outcome Measures
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Primary Outcome Measures :
  1. Detection of > 50% coronary stenosis [ Time Frame: During assessment ]
  2. Sensibility, specificity, positive and negative predictive values of MSCT [ Time Frame: During assessment ]

Secondary Outcome Measures :
  1. Detection of patients with one or more coronary stenosis [ Time Frame: During assessment ]
  2. Detection of patients with 3-vessel disease [ Time Frame: During assessment ]
  3. Left ventricle telediastolic diameter [ Time Frame: During assessment ]
  4. Septal telediastolic thickness [ Time Frame: During assessment ]
  5. Posterior wall telediastolic thickness [ Time Frame: During assessment ]
  6. Detection of coronary sinus branches [ Time Frame: During assessment ]
  7. Measurement of coronary sinus branches diameter [ Time Frame: During assessment ]
  8. Assessment of renal function 7 days after MSCT [ Time Frame: During assessment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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


Locations
France
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Dominique Boulmier, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
Study Chair: David Veillard, MD Rennes University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Direction of Clinical Research and Strategy, Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00305916     History of Changes
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

Keywords provided by Rennes University Hospital:
MSCT
Idiopathic Cardiomyopathy
Sinus rhythm

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases