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CT Coronary Angiography After Arterial Switch Operation (SCANTGV)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01153776
First received: June 29, 2010
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of this study is to find a non-invasive alternative (with using ECG gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in patients who had undergone arterial switch operation for transposition of the great arteries


Condition Intervention
Angiography,
 Procedure: 64-slice CT angiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: CT Coronary Angiography for the Detection of Reimplanted Coronary Lesions in Patients Who Had Undergone Arterial Switch Operation for Transposition of the Great Arteries

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries [ Time Frame: 30 MINUTES ] [ Designated as safety issue: No ]

    Sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries

    Expected sensitivity > 95% Expected specificity > 95%



Estimated Enrollment: 135
Study Start Date: September 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 64-slice CT angiography
64-slice CT angiography
 Procedure: 64-slice CT angiography
the sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries
Other Name: 64-slice CT angiography

Detailed Description:

Objectives To find a non-invasive alternative (with using ECG-gated 64-slice CT angiography) to invasive coronary angiography for detecting coronary lesions in children who had undergone arterial switch operation for transposition of the great arteries.

Background Assessment of the integrity of reimplanted coronary arteries is crucial for long-term outcome after arterial switch operation for transposition of the great arteries. Non-invasive tests have limited accuracy for detecting coronary lesions, and invasive coronary angiography is usually required in this setting.

Materials and methods Patients (age 4 to 30 years old) who undergone arterial switch operation in neonate period are potentially eligible. They will be prospectively included in the study. They will have both examinations, their routine invasive coronary angiography and ECG-gated 64-slice CT angiography. The ability of CT to detect lesions of the ostia and proximal segments of the reimplanted coronary arteries was analyzed by blinded comparison to invasive coronary angiogram.

Expected results and clinical implications We expect to demonstrate that ECG-gated 64-slice CT angiography is safe and accurate for the detection of coronary lesions with a high sensitivity (expected sensitivity>95%) as compared to invasive angiography. In that condition, ECG-gated 64-slice CT angiography could replace the invasive coronary angiography for the follow-up of patients with reimplanted coronary arteries after arterial switch operation for transposition of the great arteries.

  Eligibility

Ages Eligible for Study:   4 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • patients, age 4 to 30 years old, who had undergone arterial switch operation for transposition of the great arteries, are eligible.

Exclusion criteria :

  • No consent
  • Allergy to contrast agent (iodine contrast)
  • Severe renal failure (clearance < 80ml/min/1.73m²)
  • Severe arrhythmias
  • Absence of medical care insurance
  • Pregnancy
  • Contre-indication to beta-blockers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153776

Contacts
Contact: KIM-HANH LE QUAN SANG, MCU PH (0)1 44 49 51 71 ext +33 kh.lequansang@nck.aphp.fr
Contact: DAMIEN BONNET damien.bonnet@nck.aphp.fr

Locations
France
Hôpital Necker-Enfants Malades Recruiting
Paris, France, 75015
Contact: Phalla OU, MCU PH     (0)1 44 49 51 71 ext +33     phalla.ou@nck.aphp.fr    
Contact: Kim-Hanh Lequansang, MCU PH     (0)1 44 49 51 71 ext +33     kh.lequansang@nck.aphp.fr    
Principal Investigator: Phalla OU, MCU PH            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ou Phalla, MCU Ph Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Mathieu Quintin, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT01153776     History of Changes
Other Study ID Numbers: P070118, 2007-A00833-50
Study First Received: June 29, 2010
Last Updated: February 23, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Arterial switch operation,
Transposition of the great arteries,
Congenital heart diseases
CT coronary angiography,

Additional relevant MeSH terms:
Transposition of Great Vessels
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013