Multislice Spiral Computed Tomography and Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

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.

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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.

Conditions

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Cardiomyopathies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

conventional coronary angiography

Group Type ACTIVE_COMPARATOR

conventional coronary angiography

Intervention Type PROCEDURE

2

multislice spiral computed tomography coronary angiography

Group Type EXPERIMENTAL

Multislice spiral computed tomography coronary angiography

Intervention Type PROCEDURE

Interventions

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Multislice spiral computed tomography coronary angiography

Intervention Type PROCEDURE

conventional coronary angiography

Intervention Type PROCEDURE

Other Intervention Names

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MSCT

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No