Multislice Spiral Computed Tomography and Cardiomyopathy

Cardiomyopathies Clinical Trial

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Official title:

Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305916
• Other study ID #: AFSSAPS 2005/06/004
• Secondary ID: CIC0203/045LOC/0
• Status: Completed
• Phase: N/A
• First received: March 21, 2006
• Last updated: February 22, 2008
• Start date: February 2006
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies

Intervention

Procedure:
• Multislice spiral computed tomography coronary angiography

• conventional coronary angiography

Locations

Country	Name	City	State
France	Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of > 50% coronary stenosis		During assessment	No
Primary	Sensibility, specificity, positive and negative predictive values of MSCT		During assessment	No
Secondary	Detection of patients with one or more coronary stenosis		During assessment	No
Secondary	Detection of patients with 3-vessel disease		During assessment	No
Secondary	Left ventricle telediastolic diameter		During assessment	No
Secondary	Septal telediastolic thickness		During assessment	No
Secondary	Posterior wall telediastolic thickness		During assessment	No
Secondary	Detection of coronary sinus branches		During assessment	No
Secondary	Measurement of coronary sinus branches diameter		During assessment	No
Secondary	Assessment of renal function 7 days after MSCT		During assessment	No