Arterial Switch Operation Clinical Trial
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
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
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04980339 -
Multimodal Imaging Evaluation and Prognostic Analysis of Participants After Arterial Switch Operation
|