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Multislice Spiral Computed Tomography and Cardiomyopathy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00305916
Acronym
CMD-scanner
Enrollment
60
Registered
2006-03-22
Start date
2006-02-28
Completion date
2008-02-29
Last updated
2008-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathies

Keywords

MSCT, Idiopathic Cardiomyopathy, Sinus rhythm

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.

Interventions

PROCEDUREMultislice spiral computed tomography coronary angiography
PROCEDUREconventional coronary angiography

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Detection of > 50% coronary stenosisDuring assessment
Sensibility, specificity, positive and negative predictive values of MSCTDuring assessment

Secondary

MeasureTime frame
Left ventricle telediastolic diameterDuring assessment
Septal telediastolic thicknessDuring assessment
Posterior wall telediastolic thicknessDuring assessment
Detection of patients with one or more coronary stenosisDuring assessment
Measurement of coronary sinus branches diameterDuring assessment
Assessment of renal function 7 days after MSCTDuring assessment
Detection of coronary sinus branchesDuring assessment
Detection of patients with 3-vessel diseaseDuring assessment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026