Multislice Spiral Computed Tomography and Cardiomyopathy

Rennes University Hospital60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiomyopathies

Interventions

Multislice spiral computed tomography coronary angiographyPROCEDURE

conventional coronary angiographyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou

Rennes, France

Outcomes

Primary Outcomes

Detection of > 50% coronary stenosis

Time frame: During assessment

Sensibility, specificity, positive and negative predictive values of MSCT

Time frame: During assessment

Secondary Outcomes

Detection of patients with one or more coronary stenosis

Time frame: During assessment

Detection of patients with 3-vessel disease

Time frame: During assessment

Left ventricle telediastolic diameter

Time frame: During assessment

Septal telediastolic thickness

Time frame: During assessment

Posterior wall telediastolic thickness

Time frame: During assessment

Detection of coronary sinus branches

Time frame: During assessment

Measurement of coronary sinus branches diameter

Time frame: During assessment

Assessment of renal function 7 days after MSCT

Time frame: During assessment

Data from ClinicalTrials.gov

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