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Multislice Spiral Computed Tomography and Cardiomyopathy (CMD-scanner)

This study has been completed.
Sponsor:
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00305916
First received: March 21, 2006
Last updated: February 22, 2008
Last verified: February 2008
History of Changes
  Purpose
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.

Condition Intervention
Cardiomyopathies
 Procedure: Multislice spiral computed tomography coronary angiography
Procedure: conventional coronary angiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy of Multislice Spiral Computed Tomography in Diagnosis of Coronary Artery Disease Associated to Idiopathic Cardiomyopathy in Sinus Rhythm ("MSCT-IC Study").

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Detection of > 50% coronary stenosis [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Sensibility, specificity, positive and negative predictive values of MSCT [ Time Frame: During assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection of patients with one or more coronary stenosis [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Detection of patients with 3-vessel disease [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Left ventricle telediastolic diameter [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Septal telediastolic thickness [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Posterior wall telediastolic thickness [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Detection of coronary sinus branches [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Measurement of coronary sinus branches diameter [ Time Frame: During assessment ] [ Designated as safety issue: No ]
  • Assessment of renal function 7 days after MSCT [ Time Frame: During assessment ] [ Designated as safety issue: No ]
Enrollment: 60
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MSCT

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305916

Locations
France
Unité Fonctionnelle d'Hémodynamique et Cardiologie Interventionnelle - Hôpital Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Dominique Boulmier, MD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
Study Chair: David Veillard, MD Rennes University Hospital
  More Information

Responsible Party: Direction of Clinical Research and Strategy, Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00305916     History of Changes
Other Study ID Numbers: AFSSAPS 2005/06/004  CIC0203/045  LOC/04-05 
Study First Received: March 21, 2006
Last Updated: February 22, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
MSCT
Idiopathic Cardiomyopathy
Sinus rhythm

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016