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").
3 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 21, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFebruary 26, 2008
February 1, 2008
2 years
March 21, 2006
February 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Detection of > 50% coronary stenosis
During assessment
Sensibility, specificity, positive and negative predictive values of MSCT
During assessment
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORconventional coronary angiography
2
EXPERIMENTALmultislice spiral computed tomography coronary angiography
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou
Rennes, 35033, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominique Boulmier, MD
Rennes University Hospital
- STUDY CHAIR
Bruno Laviolle, MD
Rennes University Hospital
- STUDY CHAIR
David Veillard, MD
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 21, 2006
First Posted
March 22, 2006
Study Start
February 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
February 26, 2008
Record last verified: 2008-02