Multislice Spiral Computed Tomography and Cardiomyopathy (CMD-scanner)

Rennes University Hospital

Status: Completed

Conditions: Cardiomyopathies

Treatments: Procedure: Multislice spiral computed tomography coronary angiography; Procedure: conventional coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT00305916

CIC0203/045

AFSSAPS 2005/06/004

LOC/04-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Active Comparator group

Description:

conventional coronary angiography

Treatment:

Procedure: conventional coronary angiography

2

Experimental group

Description:

multislice spiral computed tomography coronary angiography

Treatment:

Procedure: Multislice spiral computed tomography coronary angiography