Multislice Spiral Computed Tomography and Cardiomyopathy

Not Applicable

Completed

• Conditions: Cardiomyopathies
• Interventions: Procedure: Multislice spiral computed tomography coronary angiography; Procedure: conventional coronary angiography

• Registration Number: NCT00305916
• Lead Sponsor: Rennes University Hospital

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Status Verified: 2008-02
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-02-22
• Last Update Posted: 2008-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Multislice spiral computed tomography coronary angiography	multislice spiral computed tomography coronary angiography
1	conventional coronary angiography	conventional coronary angiography

Primary Outcome Measures

Name	Time	Method
Detection of > 50% coronary stenosis	During assessment
Sensibility, specificity, positive and negative predictive values of MSCT	During assessment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou; 🇫🇷 Rennes, France