Skip to main content
OpenTrials
Completed

NCT Number: NCT00305916

Multislice Spiral Computed Tomography and Cardiomyopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multislice spiral computed tomography coronary angiography

Procedure

Other names: MSCT

conventional coronary angiography

Procedure

Primary outcomes

  1. Detection of > 50% coronary stenosis

    Time frame: During assessment

  2. Sensibility, specificity, positive and negative predictive values of MSCT

    Time frame: During assessment

Secondary outcomes

  1. Detection of patients with one or more coronary stenosis

    Time frame: During assessment

  2. Detection of patients with 3-vessel disease

    Time frame: During assessment

  3. Left ventricle telediastolic diameter

    Time frame: During assessment

  4. Septal telediastolic thickness

    Time frame: During assessment

  5. Posterior wall telediastolic thickness

    Time frame: During assessment

  6. Detection of coronary sinus branches

    Time frame: During assessment

  7. Measurement of coronary sinus branches diameter

    Time frame: During assessment

  8. Assessment of renal function 7 days after MSCT

    Time frame: During assessment

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: CMD-scanner

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 22, 2006
Registry last updated
Feb 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.