Multislice Spiral Computed Tomography and Cardiomyopathy (CMD-scanner)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiomyopathies
• Intervention / Treatment: Procedure: conventional coronary angiography; Procedure: Multislice spiral computed tomography 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; conventional coronary angiography	Procedure: conventional coronary angiography
Experimental: 2; multislice spiral computed tomography coronary angiography	Procedure: Multislice spiral computed tomography coronary angiography; Other Names: MSCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection of > 50% coronary stenosis	During assessment
Sensibility, specificity, positive and negative predictive values of MSCT	During assessment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Chair: Bruno Laviolle, MD, Rennes University Hospital; Principal Investigator: Dominique Boulmier, MD, Rennes University Hospital; Study Chair: David Veillard, MD, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: March 21, 2006
• First Submitted That Met QC Criteria: March 21, 2006
• First Posted (Estimate): March 22, 2006

Study Record Updates

• Last Update Posted (Estimate): February 26, 2008
• Last Update Submitted That Met QC Criteria: February 22, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Sinus rhythm; MSCT; Idiopathic Cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: AFSSAPS 2005/06/004; CIC0203/045; LOC/04-05