Clinical trial NCT00305916: Multislice Spiral Computed Tomography and Cardiomyopathy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathies
Keywords: MSCT
Idiopathic Cardiomyopathy
Sinus rhythm
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2006-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Detection of > 50% coronary stenosis
timeFrame: During assessment
measure: Sensibility, specificity, positive and negative predictive values of MSCT
timeFrame: During assessment
Secondary outcomes:
measure: Detection of patients with one or more coronary stenosis
timeFrame: During assessment
measure: Detection of patients with 3-vessel disease
timeFrame: During assessment
measure: Left ventricle telediastolic diameter
timeFrame: During assessment
measure: Septal telediastolic thickness
timeFrame: During assessment
measure: Posterior wall telediastolic thickness
timeFrame: During assessment
measure: Detection of coronary sinus branches
timeFrame: During assessment
measure: Measurement of coronary sinus branches diameter
timeFrame: During assessment
measure: Assessment of renal function 7 days after MSCT
timeFrame: During assessment
Other outcomes:
Locations:
city: Rennes
country: France
facility: Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou
Study officials:
affiliation: Rennes University Hospital
name: Dominique Boulmier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD
role: STUDY_CHAIR
affiliation: Rennes University Hospital
name: David Veillard, MD
role: STUDY_CHAIR
References: