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Multislice Spiral Computed Tomography and Cardiomyopathy (CMD-scanner)

Primary Purpose

Cardiomyopathies

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multislice spiral computed tomography coronary angiography
conventional coronary angiography
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiomyopathies focused on measuring MSCT, Idiopathic Cardiomyopathy, Sinus rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

conventional coronary angiography

multislice spiral computed tomography coronary angiography

Outcomes

Primary Outcome Measures

Detection of > 50% coronary stenosis
Sensibility, specificity, positive and negative predictive values of MSCT

Secondary Outcome Measures

Detection of patients with one or more coronary stenosis
Detection of patients with 3-vessel disease
Left ventricle telediastolic diameter
Septal telediastolic thickness
Posterior wall telediastolic thickness
Detection of coronary sinus branches
Measurement of coronary sinus branches diameter
Assessment of renal function 7 days after MSCT

Full Information

First Posted
March 21, 2006
Last Updated
February 22, 2008
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00305916
Brief Title
Multislice Spiral Computed Tomography and Cardiomyopathy
Acronym
CMD-scanner
Official Title
Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies
Keywords
MSCT, Idiopathic Cardiomyopathy, Sinus rhythm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
conventional coronary angiography
Arm Title
2
Arm Type
Experimental
Arm Description
multislice spiral computed tomography coronary angiography
Intervention Type
Procedure
Intervention Name(s)
Multislice spiral computed tomography coronary angiography
Other Intervention Name(s)
MSCT
Intervention Type
Procedure
Intervention Name(s)
conventional coronary angiography
Primary Outcome Measure Information:
Title
Detection of > 50% coronary stenosis
Time Frame
During assessment
Title
Sensibility, specificity, positive and negative predictive values of MSCT
Time Frame
During assessment
Secondary Outcome Measure Information:
Title
Detection of patients with one or more coronary stenosis
Time Frame
During assessment
Title
Detection of patients with 3-vessel disease
Time Frame
During assessment
Title
Left ventricle telediastolic diameter
Time Frame
During assessment
Title
Septal telediastolic thickness
Time Frame
During assessment
Title
Posterior wall telediastolic thickness
Time Frame
During assessment
Title
Detection of coronary sinus branches
Time Frame
During assessment
Title
Measurement of coronary sinus branches diameter
Time Frame
During assessment
Title
Assessment of renal function 7 days after MSCT
Time Frame
During assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Boulmier, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Laviolle, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Veillard, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

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Multislice Spiral Computed Tomography and Cardiomyopathy

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