Multislice Spiral Computed Tomography and Cardiomyopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm (MSCT-IC Study).

Conditions
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Cardiomyopathies

Intervention / Treatment
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* Procedure: Multislice spiral computed tomography coronary angiography
* Procedure: conventional coronary angiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>conventional coronary angiography | Procedure: conventional coronary angiography<br> <br> |
| Experimental: 2<br>multislice spiral computed tomography coronary angiography | Procedure: Multislice spiral computed tomography coronary angiography<br> <br> * Other names: MSCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of > 50% coronary stenosis |  | During assessment | 
| Sensibility, specificity, positive and negative predictive values of MSCT |  | During assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of patients with one or more coronary stenosis |  | During assessment | 
| Detection of patients with 3-vessel disease |  | During assessment | 
| Left ventricle telediastolic diameter |  | During assessment | 
| Septal telediastolic thickness |  | During assessment | 
| Posterior wall telediastolic thickness |  | During assessment | 
| Detection of coronary sinus branches |  | During assessment | 
| Measurement of coronary sinus branches diameter |  | During assessment | 
| Assessment of renal function 7 days after MSCT |  | During assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSCT, Idiopathic Cardiomyopathy, Sinus rhythm