CT Coronary Angiography After Arterial Switch Operation

Arterial Switch Operation Clinical Trial

— SCANTGV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153776
• Other study ID #: P070118
• Secondary ID: 2007-A00833-50
• Status: Completed
• Phase: N/A
• First received: June 29, 2010
• Last updated: June 27, 2017
• Start date: September 2008
• Est. completion date: October 2011

Study information

• Verified date: June 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Switch Operation
• CT Coronary Angiography
• Transposition of Great Vessels

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries	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%	30 MINUTES